Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only, Arrow In
FDA device recall Z-1472-2009 · posted 2009-06-25 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- The inflation arm tubing may separate from the stopcock adapter.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 6910 units (total all three products)
- Distribution
- Worldwide Distribution - USA and Panama.
- Date initiated
- 2009-03-25
- Date posted
- 2009-06-25
- Date terminated
- 2010-02-01
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMBOLECTOMY CATHETER (K902327) | Clincal Instruments Corp. | 1991-02-25 |