Recall Z-0552-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW
| 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 |