Recall Z-1472-2009 ยท DXE Catheter, Embolectomy
Arrow International Inc
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended for use in removing arterial emboli.
| Date | Jun 25, 2009 (initiated Mar 25, 2009) |
| Status | Terminated |
| Reason | The inflation arm tubing may separate from the stopcock adapter. |
| Root cause | Process control |
| Action | Arrow International issued an "Urgent Medical Device Recall" letter dated March 25, 2009 describing proper handling of the affected device. Consignees were also instructed to complete a Recall Acknowledgement and Stock Status Form and fax to Arrow International at 1-800-343-2935. Further questions should be directed to Arrow International, Customer Service Department at 1-800-523-8446. |
| Quantity | 6910 units (total all three products) |
| Distribution | Worldwide Distribution - USA and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902327 | EMBOLECTOMY CATHETER Clincal Instruments Corp., Feb 25, 1991 |