Recall Z-1892-2021 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
| Date | Apr 29, 2021 |
| Status | Terminated |
| Reason | Specific lots may have been manufactured with insufficient or incomplete welds. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic notified customers by letters dated April 202, via 2-day UPS delivery to consignees explaining the reason for recall and requesting they immediately identify and quarantine all unused product in their inventory. The product was to be returned. A Customer Confirmation Certificate was enclosed for completion via scan and email. If product was further distributed or transferred, the consignee was requested to notify those downstream customers or facilities of the recall. For questions regarding this notification, customers were instructed to contact Smiths Medical via email at field |
| Quantity | 2 tubing packs |
| Distribution | US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171979 | Tubing Pack Medtronic, Inc., Oct 27, 2017 |