6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA
FDA device recall Z-1634-2008 · posted 2008-08-13 · Terminated
Recall details
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Reason for recall
- Mislabeling: The part number on the product label packaging may not match the product.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 7 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-03-17
- Date posted
- 2008-08-13
- Date terminated
- 2011-07-07
- Location
- Temecula, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACS VIKING GUIDING CATHETER (K972484) | Guidant Corp. | 1997-09-26 |