Recall Z-1826-2023 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
ARROW INTERNATIONAL Inc.
ARROW Endurance Extended Dwell Peripheral Catheter System
| Date | Jun 21, 2023 (initiated May 19, 2023) |
| Status | Open, Classified |
| Reason | Potential for catheter separation or leakage |
| Root cause | Under Investigation by firm |
| Action | Arrow International/Teleflex sent customers an "URGENT MEDICAL DEVICE RECALL" letter, via FedEx, on 05/19/2023. Customers were instructed to check for affected products in inventory, immediately discontinue use and quarantine the products and complete and return the Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Should you require further inf |
| Quantity | 262,016 units |
| Distribution | Nationwide distribution. International distribution to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Feb 24, 2017 |