FDA Device Recalls in 2024
527 recalls found
February 2024
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
On November 29, 2018, the firm sent a customer letter all affected customers. All consignees were notified of the issue and informed of revised instructions for VITROS Myoglobin Calibrators: - Reconstitute the calibrators using 1.0 mL distilled water, as per current instructions. - Allow reconstituted calibrator vials to stand at room temperature for 2 hours and then proceed with calibration within 2 hours (4 hours total) - Discard reconstituted calibrators after 4 hours. - Acknowledge the information contained in this notification by completing and submitting the Confirmation of Receipt form no later than December 14, 2018. - Post this notification by each VITROS System at your facility that processes this assay or with the user documentation. - Please forward this notification if the product was distributed outside of your facility. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
In April, 2021, Draeger issued an Urgent Medical Device Correction notice to customer via letter notifying them that Draeger became aware of three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800:
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)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.
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. 1) Visually check that the secondary lane of the Interface Modules listed in Table 1 is empty before sending the Off-line command; or 2) Select the "Going to Off-line" command for the Interface Modules listed in Table 1. This ensures that the Module completes processing samples already inside the Module, releases the tubes and then passes to Off-line status. Your service provider will contact you to schedule the firmware upgrade. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check form" attached to this letter within 15 days directly to the email address specified in the email communication. Please transfer this notice to whom it might concern. 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
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
Philips issued Field Safety Notice on 11/12/21 U.S.A, Customer notified via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Start-up problem: If the start-up problem occurs, perform a Cold Restart* of the system. b) Emergency stop recovery problem: If the emergency stop recovery problem occurs, perform a new Warm Restart* of the system. c) Place this Field Safety Notice with the documentation of the system until Philips has installed a software update in your system. d) Circulate this notice to all users of this device so they are aware of the product issues. e) Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. * The system restart options are described in section 4.2 of the Instructions for Use. 5. Describe the actions planned by Philips IGT Systems to correct these problems: These problems will be resolved by a software update (available in November 2021). You will be contacted by your local Philips representative to schedule the update of your system. If you need any further information, please contact your local Philips representative (reference to FC072200502).
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
Pentax issued Urgent Medical Device Correction letter on 4/21/21 via USPS. Letter states reason for recall,health risk and action to take: We have updated our instructions for use (IFU) for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope. The warning section of the IFU has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure. In addition, the IFU has been updated to notify users of what immediate actions should be taken in case the event occurs. Please note that this documentation set is current as of this date. For updates, please refer to the PENTAX online IFU library at https://ifu.pentaxmedical.com. Customer Instructions: Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX at customeradvisories@pentaxmedical.com. Adverse events experienced with the use of this product should be reported as soon as possible to PENTAX at vigilance@pentaxmedical.com. PENTAX will issue additional communications as further information becomes available. If you have any questions regarding this action, please feel free to contact us at: : Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
The Firm, Nico Corporation, issued "URGENT: MEDICAL DEVICE RECALL" Letter dated 4/30/21 via email on 4/30/21. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY YOU Illumination Pack Field Correction 1. Determine the current number of LX Illumination Packs at your facility with the lot numbers referenced above. 2. Locate the electronic version of the updated Instructions-for-Use for LX Illumination Packs that was provided with this letter via email (document number LL-5697 03). 3. Print the updated Instructions-for-Use in a quantity sufficient to cover all LX Illumination Packs at your facility with the lot numbers referenced above. 4. Replace the existing Instructions-for-Use (LL-5697_01) with the updated Instructions for-Use (LL-5697 03). 5. Discard the existing Instructions-for-Use (LL-5697_01). LX Light Source Removal 1. Your local NICO representative will notify when he/she will be on site to deliver the return _kit for retrieval of your LX Light Source. 2. Upon receipt of the return kit, remove your LX Light Source from use and package it using the materials provided within the kit. 3. Tape the box closed, affix the prepaid shipping label and deliver it to your shipping department. 4. Upon receipt of your LX Light Source, NICO will modify it and will then return it to your local NICO representative. He/she will then coordinate with you to return it to your facility. 5. Upon receipt of your modified LX Light Source, remove it from its packaging and begin using it again. 6. Locate and print the Response Form that was provided with this letter via email. 7. Complete the Response Form (including wet signature) and email it to jay.dittman@niconeuro.com. A scanned version or a photo of the Response Form is acceptable. NICO has opened a corrective action to address this issue. If you have any questions or need additional information, please contact me jay.dittman@niconeuro.com or 317-660-7118 ext. 204
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
An Urgent Medical Device Recall notification letter dated 4/30/21 was sent to customers. Reason for the Voluntary Recall: Our sterilization contractor informed us about a quality issue possibly affecting the sterilization process of a certain number of RAND products, thus leading us to open an immediate investigation. We have determined that the lots mentioned in the table below may be non-sterile. Risk to Health: The exposure to non-sterile products may result in an increased risk of patient infection. However we have not received any adverse event report regarding patient infection events associated with this field safety notice, so far. No specific follow up activities are required if the products have already been used. Actions to be taken by the Customer/User: Please proceed as follows: 1. Please check if you still have in your stock products belonging to the lot numbers below. Please refer to the reference code (REF) and the lot number (LOT) on the product label. 2. If you identify affected product, cease use immediately and put these products in quarantine. Please be sure that they are properly and clearly identified as on-hold to prevent their unintentional use. 3. Please fill in the form on the last page and return it to cristina.vaccari@rand-biotech.com as soon as possible, but no later than May 30, 2021. The form must be completed and returned even if you do not have affected product on hand. 4. If you identified non-conforming products in your inventory, you will receive further instructions on product disposition (return them to RAND or destroy them). Type of Action by the Company: No alternative products can be used, because only RanD sterile medical devices can be used in combination with the Performer HT equipment. RanD S.p.A. has already validated a different sterilization provider. New sterile products will be available in 1 - 2 month time. Contact details: If you have any questions or concerns regarding this notification, d
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.
On July 23, 2019, a "Urgent Medical Device Recall Notification" was emailed to sales representatives. In addition to informing consignees on the cause of the recall, the following action was requested: 1. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your accounts. Response is required by August 15, 2019. 2.If affected product is found in your inventory, segregate the product and call Stryker customer service at 1-866-596-2022 or email smwest@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). Also fill out Attachment A and return to endorecall@stryker.com. 3.If affected product is found at account(s), please complete both steps below: a.Provide attached memo (Attachment B) to the account(s) to acknowledge the removal of devices and send completed memo back to endorecall@stryker.com. b.Segregate the product and call Stryker customer service at 1-866-596-2022 or email smwest@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). 4.If no product is found in your inventory or at your account(s), complete acknowledgement form on Attachment A and return it back to endorecall@stryker.com.
K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Amendia sent an Urgent Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that customers examine their inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. Customers with questions were instructed to call the following numbers: 770-575-5224 770-575-5236 770-575-5369 For questions regarding this recall call 404-610-7215.
Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.
The sound processors were loaded with the incorrect firmware.
On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.
January 2024
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.
Sensus healthcare issued an "Urgent Device Correction" to its consignees on 02/10/2023 by email. The notice requested the following actions: "Do not initiate beam delivery after a pause & resume sequence without verifying the amount of dose delivered. Do evaluate any patient treatments with version 1.9.2 that followed the pause & resume workflow. Do verify that the amount of dose to be delivered is as expected after each pause & resume sequence." The firm has developed a permanent software resolution for this issue. Customer service will contact the customer to coordinate upgrading to this revised software. Questions: Contact Sensus Customer Support at support@sensushealthcare.com or 561-578-4982
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; Kit Product Code: 80-0890 b) M-FAK Mini First Aid Kit, with Bleeding Control Dressing; Kit Product Code: 80-0891 c) M-FAK Mini First Aid Kit, Advance; Kit Product Code: 80-0892 d) M-FAK Mini First Aid Kit, Basic; Kit Product Code: 80-0913 e) M-FAK Mini First Aid Kit; Kit Product Code: 80-0914 f) Trauma and First Aid Kit; Kit Product Code: 80-0947 g) Trauma
Lack of sterility assurance of the 30-0171
North American Rescue issued an urgent medical device recall notice on August 25,2020. It state the following: This recall is only for 30-0171 NAR Responder 4" Flat Emergency Trauma Dressing. All other components packaged in the first aid kit are not affected by this recall. 1. Examine your inventory and quarantine all product and kits identified in this recall notification. 2. Discontinue all distribution or use of the recalled products identified in the recall notification. 3. Identify the 30-0171 and verify the recalled lot TSD2419 or TS00320. 4. Remove the recalled lot TS02419 or TSD0320 from the kit and quarantine. 5. Contact NAR Customer Service toll free at 1-800-689-6277 to receive credit or replacement and arrange for the return of the recalled lots. (P lease have your customer order number available to reference.) If you have further distributed this product, please Identify your customers and immediately notify them of this product recall. Please complete and return the response form as soon as possible. If you have any questions, call William Slevin at (864) 675-9800. The recall notice is posted on firm's website : www.narescue.com
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with the same staple line or tissue buttressing material (natural synthetic).
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
The firm initiated their recall by email on 09/19/2017 and followed with a letter delivered by FedEx on 09/20/2017. The notice requested the following actions: "Please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who are involved with da Vinci procedures. 1.Using the lot numbers listed above, please locate and return all affected Staplers at your site via the standard RMA process. a. Credit will be provided for remaining uses on affected instruments returned to Intuitive Surgical. 2.Please log into the da Vinci Online Community field action resource to read and/or complete any requested actions related to this issue. a. https://www.davincisurgerycommunity.com/ 3.If you cannot access the da Vinci Online Community field action resource, please complete the attached Acknowledgement Form and return it via fax or email to Intuitive Surgical per the instructions contained in the Acknowledgement Form. 4.Please retain a copy of this letter and a copy of the Acknowledgement Form for your files."
FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.
On 07/14/2021, recall notices were mailed to customers. Customers were asked to take the following actions: 1) Immediately examine your inventory and quarantine product subject to recall. 2) Return all unused inventory to the recalling firm. Please contact Customer Service at 844 352-7411. 3) Please complete the enclosed Customer Acknowledgement Form and submit to Quality@ostialflash.com. 4) Please forward a copy of this notification to those within your organization that need to be aware. Customers with additional questions or concerns are encouraged to contact Customer Service at 844-352-7411 Monday-Friday/8am-4pm PST or contact your local Field Representative.
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
The firm sent letters in June 2018, informing their customers of the issue. The firm will send labels that can be applied to the product to remind them not to plug 2 active devices into the same channel at a time. Updated 08/13/19 Starting on 06/29/18, updated Medical Device Correction Notifications and labels were mailed via second day service. Customers were asked to complete and return Business Reply Forms.
Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed.
ARCH Leg Positioning System
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
On 09/13/2021, the firm sent via certified mail an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customers informing them that the Leg Positioning System is being recalled due to a manufacturing defect that may make locking the flexion/extension carriage into position difficult under load. Customers are instructed to: 1. Contact the Recalling Firm to schedule repair of their device. 2. While customers are waiting for the repair of their device, lifting the boot to lighten the load will pushing the locking pin into place can alleviate the issue. 3. Complete and return the Acknowledgement and Receipt Form to the Recalling Firm by email or mail. The actions the Recalling Firm is taking: 1. Correcting the issue by temporarily replacing the affected part with an unaffected part while the affected part is being repaired. The repair will be taking place at the Recalling Firm's facility. 2. Implementing an additional functional test that will test the product under load. For questions and to schedule repair, contact: Suzanne Janacek, Operations Director - 409-658-1017 Monday through Friday 8:00 AM to 4:30 PM Central Time or email suzanne.janacek@iotiot.com or mail at 1115 Hwy 124, Winnie, TX 77665 email www.iotiot.com
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Product not approved for release for US distribution
Crosstex notified accounts by Urgent Medical Device Recall letter dated 3/22/22 via email. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect on-hand inventory for Ultra Pure Non-Woven Sponges, lot #202108 (part numbers ENC100 and ENC4100). 2. Please reply via email or complete the Recall Response Form included with this Notification Letter and return to cvalderrama@hu-friedy.com. Crosstex will provide instructions for returning the affected product to us. 3. Identify and notify all Customers who you have further distributed the affected product. Impacted Customers shall be provided with a copy of this letter and Recall Response Form. 4. Your Customer s Recall Response Forms shall be collected and reconciled to your distribution records to ensure all affected product is accounted for. 5. Crosstex will coordinate return of the product and credit issuance upon receipt of the completed Recall Response Form. If you have questions regarding this matter, please contact me at 312-579-9258.
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
Customers were notified via email dated 1/22/20. We request the following actions from you: 1. Please confirm receipt of this communication by emailing myself and/or your Gauss representative. 2. Please identify any of these miscolored Canister Scanning Labels in your possession: " Find the the miscolored labels by locating any package of insert + scanning label with a date of manufacture prior to to 2019-12-24. See an example below: 3. Once identified, please: " Quarantine this product and indicate this has been completed by written email response to this communication Your Gauss representative will be in contact with you this week to help resolve this issue. Replacement product will be provided immediately. Thank you for your attention to this matter. Please feel free to reach out directly to me if you have any questions.
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563
There is a potential for internal leaks within catheters.
On 7/9/2021 Edwards issued a "URGENT MEDICAL DEVICE PROUDCT CORRECTION" via FedEx to all affected consignees. In addition to informing consignees about the recall the firm ask consignees take the following actions: 1. The problem may be identified during preparation of the catheter for insertion per the IFU, paying specific attention to the connection between the green hub and the tubing for any signs of leakage. Additionally, the problem may be identified if when flushing the lumens of the catheter while administering a medication, a transient change of vital signs is observed. In either of these situations, remove the catheter over a guidewire maintaining venous access and then place a new product over the venous wire. Once properly placed, remove the guidewire, and secure the catheter. New venous access is not required. 2. Please follow the instructions included in the enclosed acknowledgement form and listed below. Return the acknowledgement form to US.FCA@edwards.com. 3. There is no need to return product at this time. 4. Distribute this notice within your organization or to any organization where the potentially affected devices have been transferred. 5. E-mail the completed form to Edwards Customer Service at US.FCA@edwards.com within 5 days from receipt of this notification. Product can be used as indicated above. If you have any questions, you may call Customer Service at 1-800-424-3278 option 1, from 5AM 4:30PM PST. 6. Advice on action to be taken by Distributor: 7. Please review this letter and complete the acknowledgement form. Return the acknowledgement form to US.FCA@edwards.com. Please forward this customer communication to any of your customers who have purchased the impacted Edwards PediaSat product and ask them to return the enclosed acknowledgement form. 8. 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 facilit