FDA Device Recalls in 2023

FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.

The firm, inpeco, sent "Urgent: Medical Device Correction" letters dated 7/14/20 to its customers. The letter described the product, problem and actions to be taken. Action to be taken by the user: Be aware that the Secondary Sample Tube flagged with error 2132 or 1442 may be diluted: discard this Secondary Sample Tube or manage it according to your laboratory guidelines. Your service provider will contact you to schedule the upgrade of the software driver and language.ini with the new error message and error recovery displayed if error 2132 or 1442 occurs. Until the service visit please maintain awareness on this notice. Please transfer this notice to whom it might concern. Please complete and return the Field Safety Notice Receipt Confirmation form attached to this letter within 15 days directly to the email address specified in the email communication. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: Regulatory.Affairs@inpeco.com Phone: (+41) 919118 224

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U

Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.

BBraun issued "URGENT MEDICAL DEVICE CORRECTION" letter on 2/7/21 to End-Users. Letter states reason for recall, health risk and action to take: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of theabove-mentioned product, and other concerned persons are informed about this voluntary correction. 2. Identify your current inventory of the affected serial (s) within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. 3. Utilizing the attached Product Correction Acknowledgement form, record the total number of individual units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Correction Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we have received your acknowledgement a BBMI representative will contact you to arrange for inspection and/or correction of the affected products. Should an issue occur, please report the event promptly to BBMI by contacting Medical Affairs Department at 1-800-854-6851.

Regard brand CABG Pack A and B - Spartanburg

Kits were packed into shipping boxes incorrectly.

An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to lacy.stewart@roiscs.com so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.

Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)

SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result

Siemens Medical Solutions USA, Inc., provided Customer Information Letter on 3/3/21 to affected customers via CT063/20/S. Customers with valid email addresses emailed a copy of the CSAN via Adobe Mega Sign. The CSAN will be distributed to the remaining customers address via hand delivery by the Siemens Customer Service Engineer. The letter states reason for recall, health risk and action to take: Siemens Healthineers has developed software update syngo.CT VA30A_SP3 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide improvements related to the general system, examination and reconstruction processes, as well as improvements for dual energy post-processing. Following the corrective action, the cause has been eliminated and recurrence of the identified issues are prevented. This software update will be provided to you free of charge. How will the corrective action be implemented? Software update CT084/20/S will be performed onsite for SOMATOM X.cite (Model #11330001). For all other systems, the update CT064/20/S will be performed remotely. The remote software updates process will require approximately 180 minutes for completion. If you have any unresolved questions or you require technical support, please contact your local application specialists or your local service/sales organization at 1-800-888-7436.

FDA Dec 26, 2023

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent

Olympus issued Urgent Medical Device Correction letter dated 12/13/21. Letter states reason for recall, health risk and action to take: 1. Please immediately perform an inspection of your installed OER-Elite units as described in the Attachment 1 Alcohol Rinse Inspection . If you require assistance, please contact your local Endoscopy Support Specialist (ESS). 2. If the inspection check does not pass, stop using the OER-Elite and endoscopes reprocessed with that OER-Elite. Contact Olympus TAC at 1-800-848-9024, option 1 for further instruction. If the inspection check passes, you may continue to use your OER-Elite. 3. Access the Olympus recall portal to indicate that you have received this notification and to report the results of the inspection. Go to https://olympusamerica.com/recall. Enter the recall number "0404" and provide your contact information as indicated in the portal. An Olympus Endoscopy Support Specialist (ESS) will reach out to you to schedule an on-site inspection of the OER-Elite detergent and alcohol tubing assembly for final confirmation. If you do not know your local ESS, please contact our Olympus TAC at 1-800-848-9024 to connect you with your local ESS. In addition, if you have further distributed this product, please reach out to those facilities and notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@Olympus.com.

FDA Dec 26, 2023

CK MB Calibrator, Catalogue Number CK2393

Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

Firm notified customers via email on March 25, 2022. The distributors and customers were instructed to discard previous target sheet and perform calibration with the realigned target value provided with the letter. Also, to complete and return the response form 12187-QA to technical.service@randox.com.

FDA Dec 26, 2023

Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N 10942012, P/N 49000007, and P/N 49000203), and Alaris Pump module Bezel Kit Assembly (P/N 10964559 and P/N 49000204). Product Usage: The Alaris Pump module is

The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.

On 04/20/18, the firm mailed Medical Device Recall Notification letters. Customers were advised that affected units outlined in the previous September 1, 2017 recall will now include affected devices with date codes September 2011 through December 2011. Customers were asked to remove the pump from use if there are signs of infusion at an unexpected rate. Use non-affected devices in high risk areas if possible. Consider having additional devices as back up until your affected devices are remediated. If the user experiences the issue described in this notification, clearly mark and sequester the devices from use and notify Support Center. Customers were asked to complete and return the Customer Response Cards to acknowledge receipt of the notification. Firm will contact all affected customers within 60 days to replace the mechanical assemblies on affected serial numbers at no charge. Customers experiencing the issue described in this notification are encouraged to call the Support Center at 888-562-6018 or email SupportCenter@carefusion.com. On 04/15/19 the firm mailed URGENT: Medical Device Recall Notification letters. Customers were advised that the firm will contact customers of Priority 1 pumps within 60 days of this notification to initiate scheduling of the inspection of those pumps. The firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Until the bezels affected by this recall are replaced by the firm, customers should inspect bezels of both Priority 1 and Priority 2 pumps during their annual preventative maintenance schedule. Any pumps with bezel post separation should be removed from service. The recalling firm will contact customers to schedule replacement of bezels in Priority 2 pumps once Priority 1 pumps have been addressed. Customers were asked to complete and return Customer Response Cards to acknowledge receipt of this notification. In addition to the Support Cente

FDA Dec 22, 2023

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to notify the clinician.

The firm notified its consignees by email beginning 03/24/2020. The notice explained the issue, risk to health, and requested a response. Distributors/pharmacy suppliers were directed to notify their customers. The firm is seeking return of the units for correction.

FDA Dec 22, 2023

ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

DePuy Synthesis issued Urgent Medical Device Recall Letter dated 1/5/22. Letter states reason for recall, health risk and action to take: 1. Carefully review the information contained in this notice. 2. Return the subject products using the normal returns process. Work with your sales consultant to ensure that the products are returned and to arrange for a replacement. To receive replacement product or reimbursement, customers must return the products subject to this notice. 3. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. The Business Response Form (BRF) must be completed and returned even if no subject product is in your possession. 4. Forward this notice to any personnel in your facility who need to be informed. 5. If any of the products subject to this notice have been forwarded to another facility, contact that facility and provide a copy of this notice to the relevant personnel. 6. Post a copy of this notice in a visible area for awareness of this notice. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda. If you have any questions, please contact your local DePuy Synthes Sales Consultant.

FDA Dec 21, 2023

MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

An URGENT MEDICAL DEVICE Recall notification letter dated 12/29/21 was sent to customers. Actions needed 1. Immediately check your internal inventory to locate the product listed on the attached business reply form. 2. Return the enclosed business reply form by email to CMF-custserv@stryker.com to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, we will contact you to arrange for the return and replacement of your affected product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform a Stryker representative if any of the subject devices have been distributed to other organizations. If so, provide contact details so that we may inform the recipients appropriately. If you have any questions or concerns, please contact Customer Service +1 800 962-6558.

FDA Dec 20, 2023

Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610

Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life

Boston Scientific issued Notifications to consignees via Federal Express Priority mail on October 21, 2019. The notification instructs the account to check their inventory remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.

FDA Dec 20, 2023

NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.

Firm discovered a firmware memory leak with a supplier-manufactured component.

The firm, Hillrom, issued an "Urgent Medical Device Correction Notice", dated 04/13/2022, to impacted consignees via email. The consignee is instructed to identify if they have the impacted product component, Part P2519NNC3A2 and also distribute the notification to personnel as well ensure that the users monitor for system alerts. Notify Hillrom Technical support if there is a loss of connectivity to the nurse call server. Note, error indications will display on multiple user interfaces. Central nurses' stations will state the room(s) is down (disconnected). In patient room(s), graphical audio stations will display clear message stating Station down. Contact Nurse directly . In addition, standard audio stations will have an LED Error state indicator. Complete and return the response form to william.knouse@hillrom.com. Hillrom is testing a firmware update for the Power over Ethernet (PoE) switch and anticipates availability in April 2022. Upon receipt of the response form, Hillrom will contact you to schedule an update to your system once firmware is available. If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at +1 919 854 3361 or william.knouse@hillrom.com

FDA Dec 19, 2023

syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

4/4/22 update: Urgent Medical Device Correction letter has not been issued. The proposed letter informs customers of software issue and workaround to resolve issue. It also requires electronic signature to acknowledge receipt of the notification. If you have additional questions contact the service organization at 1-800-888-7436.

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.

On October 15, 2021, the firm issued "Important Product Correction Notification" letters to affected customers. Customers were informed that up to 8 booklets in the affected lot contained the range of means information for VITROS Immunodiagnostic Products Anti-HBc Controls instead of the control values for VITROS Anti-HBc IgM. Customers were provided with a copy of the correct Controls Values booklet. Customers were asked to do the following: - Complete and return the included Confirmation of Receipt - Response Required customer response form by email to: ra-ocdus-confirmad@orthoclinicaldiagnostics.com or fax to: 1-888-557-3759 or 1-585-453-4110 - Retain the included Controls Values booklet to use in place of any recalled booklets - Forward the notification if the product was distributed outside your facility If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

On 11/09/21, Field Safety Notices and updated Instructions for Use, Rev. 6 2021, were emailed to customers. Customers were asked to take the following actions: 1.Please ensure the updated Instructions for Use are distributed to the necessary persons within the organization and that they are adhered to when selecting and using the Miami J Select device. A copy of the updated instructions accompanies this notice. 2.Please pass this notice to those who need to be aware within your organization or to any organization where the listed devices have been transferred. 3.Please retain this letter in a prominent position for one month. 4.If you have further distributed this product, please identify your customers, and notify them at once of this Field Safety Notice. We recommend that you include a copy of this notice. 5.Reply to the email that you received confirming receipt of this notice and the updated instructions for use, even if your facility is no longer in possession of affected devices. Customers are encouraged to contact customer service for further information and assistance: U.S. 1-800-233-6263

DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.

DeRoyal issued their recall on 09/03/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal.

VITROS XT3400 Chemistry System, Product code 6844458

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

The firm notified customers through Urgent Product Correction Notification letters on July 20, 2020. Customers were informed of the potential issue with incubator slot 18 of affected devices. Customers were provided with a table of the eight assays with biases which do not align with the assay's intended clinical use. Customers who had already been identified as experiencing this issue through their e-connected systems, or who did not have e-connected systems, received a letter stating that the recalling firm would be replacing the CM Rotor to resolve the issue. Customers who had e-connected systems but who had not yet been identified as experiencing this issue were informed that Ortho would continue to monitor their system for an increase in the frequency of condition codes related to slide misalignment. If impacted, those customers would also receive a replacement CM Rotor. Customer actions: " If you suspect an erroneous result has occurred or you observe an increase in the frequency of TH4-60J/TH4-63J condition codes, contact Ortho Care Technical Solutions Center. " Review the enclosed Assay Observed Bias sheet for VITROS Slides assays used by your laboratory. Discuss any concerns with your Laboratory Medical Director. " Complete the Confirmation of Receipt form and return to the firm " Post this notification by each VITROS XT 3400 and/or XT 7600 System in your facility or with the user documentation.

FDA Dec 15, 2023

Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chair (wheelchair)

Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.

The firm notified the US importer by email on 03/28/2019. The letter explained the problem and requested that the plastic joint connecting the back to the seat base be replaced. The importer will notify the distributors (dealers) of the issue and provide the replacement kits when they arrive. The distributors (dealers) will be performing the field corrections.

FDA Dec 15, 2023

Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.

Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.

On February 26, 2021 Stryker sent a "Urgent Medical Device Recall notification via mail to all affected consignees. In addition, to informing consignees about the reason for a recall, the firm ask consignees to take the following actions: 1. Immediately check inventory to locate the product listed on Attachment A and remove them from their point of use. 2. Return the enclosed business reply form by email to endorecall@stryker.com to confirm receipt of this notification/document product segregation. RESPONSE IS REQUIRED. a. If affected product is found, segregate the product and call Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return and receive a replacement (upon availability) and complete Business Reply form, Attachment B on page 3. b. If no product is found, complete Business Reply form, Attachment B on page 3 of this recall letter. 3. Maintain awareness of this communication internally until all required actions have been completed. 4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. If you have any questions or concerns, please email endorecall@stryker.com.

FDA Dec 15, 2023

Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.

Getinge issued a An Urgent Medical Device Correction to U.S. consignees on 5/20/19 via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of the issue, health risk and action to take: examine your inventory immediately, Until the required correction has been completed, take the following precautions detailed in the User Manual: Do not operate the machine unattended. Always inspect the processed goods after a wash cycle. Contact a Getinge Service person if either of these are noticed: o If the washer starts to sound different than usual during a wash cycle, abort the process and call your service person.o Goods are not cleaned after the process is finished. Getinge Service person will contact the person you listed on the Customer Response Form to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getingetrained or authorized service technician by calling Getinge Customer Support at 18009509912 (select option 1). Customer Service hours: 8:00 AM to 5:00 PM (EST) Monday to Friday

FDA Dec 14, 2023

Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507

There is a potential that the pressure tubing may detach from the blood sampling system

On May 26, 2021 Edwards Lifesciences issued a "Urgent Medical Device Recall" Notification via FedEx to all affected consignees. In addition to informing consignees about the recalled product, the firm asked consignees to take the following actions: 1. Action to be taken by user: We request that you return all unused product in your inventory with the model and lot numbered reference above. For product that has been used and will be returned, please contact Customer Service at 1-800-424-3278 to request a biokit. Please review your inventory and quarantine any affected product until prepared for return to Edwards Lifesciences. Please follow the instructions included in the enclosed acknowledgement form an return within 5 days of receipt of this notification. 2. Action to be taken by distributor: Please complete the acknowledgement form and return to US.FCA@edwards.com. Please forward this customer communication to any of your customers who have purchased the impacted Edwards VAMP Jr. and TruWave/VAMP Jr. Products and ask them to return the product toe Edwards with the enclosed acknowledgement form. 3. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product and Edwards will communicate directly with your customers to facilitate the recall and acknowledgement process. Please forward your customer list to US.FCA@edwards.com 4. Adverse Event Reporting in the US: - Please contact the FDA's MedWatch Adverse Event reporting program either online, by regular mail, or by fa: Complete and submit the report Online: WWW.fda.gov/medwatch/report.htm - Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 5. Transmission of the Product Recall: This notice need to be passed on to all individuals within your organization who need to be aware of th

FDA Dec 14, 2023

Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment

Cardinal Health issued letter Urgent Medical Device Recall EVENT-2020-02846 on 4/30/20 via overnight mail. Letter states reason for recall, health risk, and action to take: 1. CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers 2. SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Exhibit A. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other Customers888-444-5440 Questions contact: Cardinal Health 800-292-9332

FDA Dec 12, 2023

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Kits failed sterility testing and showed evidence of contamination.

The firm distributed a notice to customers dated 07/06/2020 via email stating that lots 1029, 1029A, and 1029B need to be quarantined pending further investigation. Customers with questions are asked to contact Renee Schlick, Quality Assurance Manager, at 608-838-1640 or by email at rschlick@gentueri.com.

FDA Dec 12, 2023

Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).

A software error was detected within software version 1.3.4 for the Tempus LS device. When exiting pacer back into manual mode the pacer pulse wave may put the ECG calibration out of calibration. This software error may result in a delay in therapy, as the clinician is not provided an ECG waveform on which a shockable rhythm decision can be made. The device is still able to deliver a manual defibrillation shock.

Customers are asked to follow the "Action to be Taken by Customer/User" section of the recall notice which states the following : The device continues to be able to deliver defibrillation therapy if this fault condition occurs. The problem is resolved by: - Manually exiting Pacer mode into Manual defibrillation mode, and then must power cycle the device by: - Holding the power button to turn the device off and then power on again using the power button. The device will restart in the default manual defibrillation mode. Alternatively, switching to a different Defibrillator may be used to monitor ECG waveform and perform a defibrillation shock. Please complete the attached reply card, so that RDT may provide the USB Flash Drive to the correct location and recipient to upgrade your device/s. Once you receive the USB Flash Drive, follow the instructions to upgrade the device/s.

FDA Dec 12, 2023

Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol) ratio a

The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.

On 2/15/2019, the firm provided a urgent medical device recall letter to all consignees who received the affected product. The letter was provided in a combination of methods to those consignees via direct mail, email or fax. The letter informed consignees of the following: 1. Alere San Diego, Inc. has concurrently sent a replacement Alere Cholestech LDX Power Supply at no extra cost to your shipping address on record via FedEx. Please refer to Purchase Order Number ASD119LDX for the replacement shipment. 2. " Discontinue use of and discard the affected Alere Cholestech LDX Power Supply. 3. If you have forwarded the product listed above to another facility, please provide a copy of this letter to them. 4. Complete and FAX or email the enclosed Verification Form within 10 days to confirm your receipt of this notice. 5. If you need to report any concerns you may have about the performance of the Alere Cholestech LDX System, please contact Technical Services at 1-877-308-8289 or by email at LDX.Support@alere.com. If you have questions, please contact Alere San Diego, Inc at 1-877-308-8289

FDA Dec 11, 2023

Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.

Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.

On December 18, 2020, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were informed that the service life of the LCSU 4 may be reduced. Customers were asked to identify and secure affected units. Customers were told that they could continue to use their LCSU 4 unit until they receive a replacement unit, but were provided with safety measures: - Follow local protocols for back-up suction devices. Do not repeatedly block the patient tube for more than 10 seconds at a time at vacuum levels greater than 300 mmHg. - Only use canisters, tubes and accessories that are approved for the device by Laerdal Medical. - When adjusting the vacuum level: When the desired vacuum level is reached; unblock the patient tube immediately. - During patient treatment do not occlude or block the patient tube by intentional bending or squeezing. The patient tube should only be temporarily occluded by suctioning matter. - When performing the Device Test: When the vacuum reaches minimum 500 mmHg immediately release the blocking. - If your affected LCSU 4 experiences a loss of peak suction, please report this to your local Laerdal Sales office, for US: 877-LAERDAL (523-7325), customerservice@laerdal.com or, for Canada: (416) 298-9600, savelives@laerdal.com Customers must complete the included reply form to acknowledge receipt of the recall notice and to identify any units needing replacement, and return the information to Stericycle.

FDA Dec 11, 2023

Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.

A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted

Siemens Medical Solutions USA, Inc. issued Customer Safety Advisory Notice to customers via XP051/20/S on 3/10/21. Letter states reason for recall, health risk and action to take: It is advised for the user to check the image displayed following image recovery to ensure that it is a newly acquired image of the current patient. If the operator detects the error, the image should be deleted, and Siemens Customer Service should be notified. Siemens Healthineers will provide a field software update VA10D for YSIO X.pree units that will eliminate the issue described. The software update will be disturbed to all potentially affected users via an Update Instruction XP052/20/S. Apart from the described correction, the updated software contains further stability, usability, and performance improvements. This resolution will be provided free of charge and is planned will be available in the second quarter of calendar year 2021. Your local Siemens Healthineers Service organization will contact you as soon as the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice. Additionally, a software solution VA10D to eliminate the root cause of this problem will be distributed via XP052/20/S. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented.

FDA Dec 11, 2023

JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035821 SIZE 2, CATALOG NUMBER: REF 74035822 SIZE 3, CATALOG NUMBER: REF 74035823 SIZE 4, CATALOG NUMBER: REF 74035824 SIZE 5,

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

The firm initiated the recall by email on 01/28/2020. The initial consignee notified the district sales representatives on 01/28/2020 by email. The district sales representatives checked their inventory and the inventory of the hospital they service.

FDA Dec 8, 2023

Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)

Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.

A Consignee Notification with response form was sent to affected consignees on 12/20/2017.

FDA Dec 8, 2023

BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.

Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.

The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" Customer Notification Letter and attached Recall Effectiveness Check Form to Stryker Sustainability Solutions (SSS) sales representatives and international Stryker divisions to notify affected customers beginning on 12/17/2018.The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Use of the affected product(s) should be discontinued. 1) Please check your inventory for the affected devices. Affected devices may be identified through Serial Number or Expiration Date. 2) Please complete the Urgent Medical Device Recall Effectiveness Check Form (page 5) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker Sustainability Solutions Sales Rep c. Fax: 480-763-5345. This form must be completed and returned to Stryker even if no affected product is found. If you have any questions, contact Manager, Post-Market Surveillance, at 888-888-3433 or email: marissa.richmond@stryker.com.

FDA Dec 7, 2023

VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

Ortho Clinical Diagnostics issued Urgent Product Correction Notice on 30 Sept 2020 via(CL2020-246) of the issue and instructed as follows: If they are unable to calibrate (now or in the future) using an affected lot of VITROS Anti-SARS-CoV-2 IgG Calibrator Ortho will replace their remaining inventory as indicated on their Confirmation of Receipt form. NOTE: If they have a successful calibration, and quality control results are acceptable, the laboratory may continue using the affected lots for qualitative detection of IgG antibodies to SARS-CoV-2. If they are using the affected product to qualify units as high titer for CPT, consult with your medical director to determine if they should continue testing while waiting for their replacement product. Ortho will replace or credit their remaining inventory as indicated on their Confirmation of Receipt form. Post this notification by each system that processes the affected lots of VITROS Anti-SARS-CoV-2 IgG Calibrator or Control. Complete the enclosed Confirmation of Receipt form no later than October 9, 2020. Indicate the quantity of their remaining inventory to be replaced or credited. Please forward this notification if the product was distributed outside of their facility

FDA Dec 7, 2023

Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu King LTS-D" Supraglottic Airway.

Kit contained an incorrect catheter-tip syringe not compatible with the luer lock connector of the included airway. As a result, may be unable to inflate the balloons of the supraglottic airway to create a secure seal in the patient s airway as intended by the kit

The firm, Bound Tree, issued "URGENT NOTICE OF RECALL" letter by mail on May 14, 2020 and Bound Tree Customer Service and followed with email or telephone calls. Letter states reason for recall and action to take: Please immediately physically review your inventory of this kit and lot number for the affected syringe . Should you determine your inventory contains affected product, please quarantine affected kits immediately and contact Boundtree customer care to return product for replacement or credit. Questions pertaining to the recall, you may contact Boundtree customer care at 800-533-0523.

November 2023

FDA Nov 30, 2023

Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

The firm initiated their field notification by letter on November 25, 2019. The letter states the reason for recall and provides the following safety instructions: You can continue to use the anesthesia system. - If you observe the message Ventilate Manually! , change from mechanical to manual ventilation. At any time, the clinician may use a self-inflating bag to ventilate the patient and/or switch to another anesthesia device. Contact your GE Healthcare representative for repair of the device. - Perform the planned maintenance (PM) every 12-months at a minimum per the User s Reference Manual which includes inspection of the cable connection. Note: This inspection step is included in the annual PM described in the Technical Reference Manual. Performing this step in the PM would confirm the integrity of the cable connection. Contact Information: If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. The firm will be correcting the units. The firm issued a Press Release on January 13, 2020.

HeartStart XL+ Defibrillator/Monitor, Model 861290

The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.

On October 16, 2019, Philips Healthcare issued Urgent Medical Device Correction notices to U.S. customers via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Actions to be taken by the customer: 1) The device is safe to use and can remain in service if it does not exhibit any of these behaviors described in this Notice. 2) Continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure during use. 3) If you identify a device that exhibit any of these behaviors; please remove it from service and contact Philips to request service. Philips will contact you to arrange for repair of your unit once parts are available. Philips will install a replacement switch in affected devices at no charge to the customer. If you need further information or support concerning this notification, please contact your local Philips representative.

INFX-8000F Fluoroscopic X-Ray Systems

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited ceiling support device can be overridden by pressing the override switch on the left side of the operation console. If any abnormalities are found during use, please stop using your system and contact your Toshiba service representative. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.

Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12

Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

Ethicon issued Urgent Medical Device Removal Letter on 1/4/21 via UPS second day. Receipt of the letter will be confirmed via UPS tracking. Letter states reason for recall, health risk, action to take: 1.Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 866-853-2807 or Ethicon5582@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 6. Customers are required to return unused impacted Dermabond Advanced" Topical Skin Adhesive subject to this recall that are in their inventory immediately. To receive replacement reimbursement, customers must return product subject to this recall no later than April 9, 2021. Any non-affected product and any product returned after the date specified will not receive replacement. 7. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling 800-

The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to ci

Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.

On 04/30/2021, Terumo issued an Urgent Medical Device Removal notice to customer via letter notifying users to discontinue the use of and dispose of HX2, TCM I and TCM II devices. Customers were instructed to confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. For questions contact Terumo CVS Customer Service: 1-800-521-2818.

Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.

Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.

Customers were notified on about 03/30/2018 via an Urgent Medical Device Safety Notice. Instructions included to review the field safety notice and understand the potential hazard, review the recall with appropriate clinical staff at their institution, complete and return the acknowledgement form, and distribute the notification within the organization where potentially affected devices may have been transferred. Questions can be directed to Edwards Customer Service, Monday through Friday at 800-424-3278 form 8:00 AM - 4:00 PM Pacific Time.

NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test

Incorrect hCG results

Emails were sent to Distributors and Medical Facilities on 09/21/2016. Follow up phone calls also were made.