Recall Z-0551-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP
| Date | Feb 18, 2005 (initiated Sep 21, 2004) |
| Status | Terminated |
| Reason | Product was mislabeled for lumen configuration, flow rates, and priming volume. |
| Root cause | Other |
| Action | The recalling firm telephoned the hospital accounts on 9/21/04 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, a recall letter dated 9/21/04 was sent via FedEx to the hospitals. |
| Quantity | 25 kits |
| Distribution | The products were shipped to hospitals in AZ, CA, NJ, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930129 | ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER Arrow Intl., Inc., Mar 28, 1994 |