Recall Z-2911-2016 ยท DXE Catheter, Embolectomy
Arrow International Inc
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
| Date | Jul 7, 2016 |
| Status | Terminated |
| Reason | Arrow is recalling due to incorrect labeling of products. |
| Root cause | Component design/selection |
| Action | The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated July 07, 2016 via FedEx to its customers. The letter described the product, problems and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products they may have on hand; return product, and complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com, even if you have no affected stock. If you have any other questions, feel free to contact your local sales represent |
| Quantity | 2,425 catheters |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902327 | EMBOLECTOMY CATHETER Clincal Instruments Corp., Feb 25, 1991 |