Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Ar
FDA device recall Z-1538-2010 · posted 2010-05-05 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Some central venous catheter sets had the incorrect lid stock.
- Action taken
- Consignees were notified by an Urgent Medical Device Recall letter on/about 12/15/2009. The letter identified the affected product and stated the reason for the recall. Customers were instructed to immediately check their stock and cease use, distribution, and quarantine affected product. They are also to contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to return any affected product along with the Advisory Acknowledgement and Stock Status Form. Arrow will either provide replacement with a similar product or credit customers' accounts. Customer Service can be contacted with questions or for clarification.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KGZ
- Quantity affected
- 295 kits
- Distribution
- Nationwide Distribution -- MA.
- Date initiated
- 2009-12-15
- Date posted
- 2010-05-05
- Date terminated
- 2011-07-29
- 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 |
|---|---|---|
| ADAPTER, CATHETER SHEATH (K781846) | Arrow Intl., Inc. | 1978-12-12 |