Recall Z-1633-2008 ยท DQY Catheter, Percutaneous
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a pathway trough which therapeutic and diagnostic devices are introduced.
| Date | Aug 13, 2008 (initiated Mar 17, 2008) |
| Status | Terminated |
| Reason | Mislabeling: The part number on the product label packaging may not match the product. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified via an Urgent Device Recall letter dated and hand delivered starting 3/18/08. The letter requests users to remove and quarantine the affected lots, which will be picked up and replaced by the recalling firm. Users were also requested to return the enclosed Efficiency Check Reconciliation Form. Abbott Vascular will exchange all returned devices. For additional information contact 1-800-227-9902. |
| Quantity | 10 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972484 | ACS VIKING GUIDING CATHETER Guidant Corp., Sep 26, 1997 |