Recall Z-0003-2022 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
| Date | Sep 13, 2021 |
| Status | Open, Classified |
| Reason | There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. |
| Root 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 a |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190557 | Bio-Medicus Insertion Kit Medtronic, Inc., Apr 3, 2019 |