FDA Device Recalls in 2023

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium

QC process was not adequate for the specification range.

A customer letter, dated 03/24/2022, was emailed to the impacted consignee. The consignee is instructed to destroy the product as it is now past its updated expiration date. The consignee is asked to complete the response form and submit to the recalling firm.

System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition

GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be damaged or missing leading to exposed table screws which could cause a laceration due to a sharp edge.

The manufacturer sent an "Urgent Medical Device Correction" letter (GEHC Ref# 25496) to customers with affected systems on 12/17/2020.

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only.

Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.

Medline sent an "URGENT RECALL NOTIFICATION" on 01/15/2021 to customers, requesting: 1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. If you have any questions, please contact 866-359-1704.

Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.

The firm sent a recall communication letter "Urgent: MEDICAL DEVICE RECALL IMMEDIATE ATTENTION REQUIRED" to customers on 01/11/2021.

RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.

Product was compromised during shipment.

The firm notified their consignees by letter on 01/25/2021. The letter explained the problem and requested destruction of the product.

Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.

Philips issued Customer Information Medical Device Correction (CIL86201894B) via priority mail on 6/8/20. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: To check if this issue affects your M3015A, compare the serial number of your device with the affected serial numbers identified; Use affected M3015A extensions only together with an lntelliVue X2 or MMS.; Do not combine an affected M3015A with an lntelliVue X3 or MMX; Philips Healthcare is distributing with this letter an addendum to the Instructions for Use for patient monitors that include directions for the use of the M3015A (MX100/X3, MX400-800 and MX750/MX850). If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800-722-9377.

FDA Jan 7, 2023

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400

A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

Urgent Medical Device Correction notification letters dated 5/20/20 were sent to customers. ACTIONS TO BE TAKEN BY FACILITIES (Immediate): Please immediately check your inventory of Arrow AutoCAT2 and Arrow AC3 Optimus IABPs, whether stored or in use, and determine if you have an IABP with a model number listed above. Please see Appendix 1 for product codes and serial numbers. If an IABP in the scope of this Medical Device Correction displays a System Error 3 or High Baseline alarm, now or at any point in the future until the Long-Term Corrective Action detailed below occurs, immediately quarantine the device and contact Teleflex at 1-855-419-8507 or recalls@teleflex.com to receive support for inspection and servicing of the impacted device. We recommend against using an IABP for ground or air transport between medical facilities pending implementation of the Customer Action (Long Term). For IABP use during ground or air transport prior to implementation of the Customer Action (Long Term), it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered. Customer Action (Subsequent): Teleflex will contact each impacted facility to schedule inspection and servicing of all IABP units that contain this internal component. This inspection and servicing will be performed onsite at facilities, for all IABP units. Facilities should adhere to the following instructions pending implementation of the Teleflex Long-Term Corrective Action described later in this letter: 1. Ensure that a backup IABP is available as instructed within the Operator Manual. If no such replacement IABP is immediately available, it is recommended that the risks and benefits of using the IABP be assessed by the medical team treating the patient and that alternative circulatory support devices be considered. 2. IABP units should be closely monitored during delivery of IAB

FDA Jan 6, 2023

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

The package contents and package labeling do not match.

Affected consignees were notified via email and/or Federal Express mail. Consignees are asked to immediately quarantine all recalled products on hand and return all affected product to Wright Medical Arlington TN Warehouse as soon as possible. If the consignee has further distributed the affected product, they are asked to notify the applicable parties at once about this recall. The consignee may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.

FDA Jan 6, 2023

Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.

The firm distributed an Urgent Recall Notification, dated 11/30/2021, to customers who purchased recalled product via first class mail. The notification informs customers that the firm is initiating a removal of Trilevel Serum Matrix Free from S-O2460605 kits due to product being compromised during shipment. Customers are instructed to immediately check their stock for affected product, quarantine any lot numbers associated with the recall, and destroy affected product. Customers were provided an Urgent Remedial Action Destruction Form to complete and return to the firm to indicate whether or not they possess recalled product and document product destruction. Completed forms are to be returned to the firm via email at recalls@medline.com or by fax at 866-767-1290. If product was further distributed, customers are required to share the recall notification down the distribution chain. Customers with any questions about the recall are instructed to call 866-359-1704.

FDA Jan 6, 2023

Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;

Manufacturing packaging error.

On 11/02/2020 the firm send a letter to its consignees with the following instructions: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.

Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

Bottles Missing Product Label

Fresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.

MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.

The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

A Recall notification letter titled, "Medical Device Removal - Immediate Action Required" was sent to the OUS consignees on 03/05/2021 and the U.S. consignees on 03/08/2021 via overnight mail delivery. Customers outside of the US were either contacted via letter delivery or email. The recalling firm requested if the consignees identify any product from the listed batch within their inventory, to please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. The consignees will receive replacement product for all removed product returned to Boston Scientific. Distributors are also informed in the letter that the removal depth is to the hospital level and the removal notification should be forwarded to their customers. The field removal letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating they have received the field removal and followed the included instructions.

Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).

Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.

On 03/17/2021, Stryker issued an Urgent Medical Device Recall notice to customers and distributers via letter because the firm identified non-conforming components of the Titanium X TL sets which could lead to device failure in the field.

Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.

The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.

In May, 2021, Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" notice to customers via letter notifying them Medtronic is voluntarily recalling certain lots of Angiographic Guidewire components. In June 2021, Medtronic issued AMENDED URGENT MEDICAL DEVICE RECALL notices to customers. On The component part numbers associated with this recall are intended for shipment to a third-party, where they are further processed into kits and sterilized, but were instead shipped directly to customers. Actions: Medtronic records indicate that your facility has received one or more of the affected Angiographic Guidewire components. As a result, Medtronic requests that you immediately take the following actions: -Identify and quarantine all unused affected components identified in the customer letter. -Utilize standard hospital practice and policies to notify patients who were treated with the recalled components. -Return/Exchange all unused affected components in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-716-6700 to initiate a component return/exchange. Your local Medtronic Representative can assist you in the return of this component. Please refer to Table 2 for applicable part numbers to facilitate reordering. -Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. If you have any questions regarding this communication, please contact your Medtronic Field Representative or call:763-526 -8583 or email: rs.cvgrecalls@medtronic.com.

Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.

There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.

The recalling firm issued an Advisory Notice Information dated 2020-06-30 on 7/2/2021 via email which explained the reason for recall and that they would be contacted as soon as possible to proceed with the exchange. On 9/24/2021, a Returned Goods Authorization Form was sent to the consignees so the adapter could be exchanged.

ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

Medline contacted affected consignee via telephone on 10/22/2021 and confirmed that the product had been destroyed.

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201

The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.

Cardinal Health issued Urgent Medical Device Correction letter and Acknowledgement Form on June 16, 2021 to the direct consignees. Letter states reason for recall, health risk and action to take: Actions Required: 1) REVIEW the IFU for the Safety Scalpel N11 (vendor part number 73-1811). 2) COMMUNICATE the IFU to all personnel that utilize the Argyle" UVC Insertion Tray (SKU 43201) containing Safety Scalpel N11 (vendor part number 73-1811) 3) NOTIFY any customers to whom you may have distributed/forwarded affected product or will send the product about this product correction notice and share a copy of this notice and the attached IFU. 4) POST a copy of this notification in the location where the product is stored. 5) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com whether or not you have affected product. Available Assistance: Please contact the Customer Service group for any questions or to arrange for credit and return of any product: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All other customers 888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.