Recall Z-1248-2021 ยท DQY Catheter, Percutaneous
Medtronic Vascular
Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
| Date | Jan 15, 2021 |
| Status | Terminated |
| Reason | Sterility may be compromised due to an unsealed pouch |
| Root cause | Process control |
| Action | Medtronic issued 15-Jan-2021 Medical Device Correction letter via UPS 2-day to consignees stating reason for recall, health risk, and action to take: Medtronic records indicate that your facility has received one or more of the affected Launcher Guide Catheters. As a result, Medtronic requests that you immediately take the following actions: "Identify and quarantine all unused affected 6F Launcher Guide Catheters as listed in the table above. "Return/Exchange all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at1-800-716-6700 to initiate a product r |
| Quantity | 137 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021256 | Z3 GUIDE CATHETER Medtronic Vascular, May 17, 2002 |