Class 2 Device Recall BioMedicus" Insertion Kits

• Date Initiated by Firm: September 13, 2021
• Create Date: October 01, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0003-2022
• Recall Event ID: 88685
• 510(K)Number: K190557
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
• Code Information: Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
• Recalling Firm/ Manufacturer: Medtronic Perfusion Systems; 7611 Northland Dr N; Brooklyn Park MN 55428-1088
• For Additional Information Contact: 800-854-3570
• Manufacturer Reason for Recall: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued letters dated September 2021 beginning 9/13/2021 via 2-day UPS delivery to consignees. For outside of the United States, the recall letter will be delivered via regionally-approved methods to consignees who received the product. The letter explains the issue and requests the consignee review their inventory for the affected product. The product is to be immediately quarantined and returned after first contacting Customer Service. A Customer Confirmation Form was enclosed to be returned via email. The letter was to be shared with others within their organization as appropriate and to any other locations who have received the product through a transfer. Consignees are asked to review the Medtronic Urgent Medical Device Recall notification and follow the Recommended Actions, including quarantining and returning all unused affected Bio-Medicus Insertion Kits in their inventory.
• Quantity in Commerce: 168 kits
• Distribution: Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DWF and Original Applicant = Medtronic, Inc.