Class 2 Device Recall Edwards Blood Management System

• Date Initiated by Firm: May 26, 2021
• Create Date: June 25, 2021
• Recall Status: Terminated on December 14, 2023
• Recall Number: Z-1962-2021
• Recall Event ID: 87993
• 510(K)Number: K142749 K161962
• Product Classification: Transducer, pressure, catheter tip - Product Code DXO
• Product: Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
• Code Information: Lot # 63456332
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: Linnette Torres; 949-250-6827
• Manufacturer Reason for Recall: There is a potential that the pressure tubing may detach from the blood sampling system
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 2,000 units
• Distribution: US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXO; 510(K)s with Product Code = DXO