Recall Z-1194-2018 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
| Date | Mar 14, 2018 (initiated Dec 15, 2017) |
| Status | Terminated |
| Reason | Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries. |
| Root cause | Process control |
| Action | Notification letters were sent to consignees with the following instructions: 1. If you have affected stock, quarantine so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to Arrow. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to Arrow. |
| Quantity | 305 |
| Distribution | Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System Arrow Internation, Inc. (Subsidiary of Teleflex Inc.), Jul 8, 2015 |