Recall Z-1409-04 ยท GBW Catheter, Peritoneal
Arrow International Inc
Peritoneal Lavage Kits, Model number AK-09001
| Date | Aug 25, 2004 (initiated Aug 2, 2004) |
| Status | Terminated |
| Reason | wrong introducer needle in some kits |
| Root cause | Other |
| Action | The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product. |
| Quantity | 9100 units |
| Distribution | The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.