Recall Z-1471-2009
Arrow International Inc · initiated March 25, 2009
Product
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, 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.
Codes / lots: Lot Numbers: CF8024537, CF8035837, CF8036331, CF8036759, CF8047807, CF8059710, CF8060585, CF8062240, CF8072762, CF8074445, CF7084561, CF8096988, CF8097442, CF8097705, CF8100439, CF8109029, CF8109961, CF8110887, CF8111320, CF8111840 and CF8112312.
Reason for recall
The inflation arm tubing may separate from the stopcock adapter.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1471-2009
- Initiated
- March 25, 2009
- Posted by FDA
- June 25, 2009
- Terminated
- February 1, 2010
- Product code
- DXE – Catheter, Embolectomy
- Quantity
- 6910 units (total all three products)
- Distribution
- Worldwide Distribution - USA and Panama.
- Recalling firm
- Arrow International Inc, Reading, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1472-2009 | Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single…The inflation arm tubing may separate from the stopcock adapter. | 03/25/2009Terminated |
| Z-1473-2009 | Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single…The inflation arm tubing may separate from the stopcock adapter. | 03/25/2009Terminated |