Recall Z-1538-2010 ยท KGZ Accessories, Catheter
Arrow International Inc
Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605 Permits venous access and catheter introduction to the central circulation.
| Date | May 5, 2010 (initiated Dec 15, 2009) |
| Status | Terminated |
| Reason | Some central venous catheter sets had the incorrect lid stock. |
| Root cause | Packaging |
| Action | 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' acc |
| Quantity | 295 kits |
| Distribution | Nationwide Distribution -- MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K781846 | ADAPTER, CATHETER SHEATH Arrow Intl., Inc., Dec 12, 1978 |