Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vasc
FDA device recall Z-1178-2010 · posted 2010-03-22 · Terminated
Recall details
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Reason for recall
- Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.
- Action taken
- Abbott Vascular issued an "Urgent Device Recall" notification dated May 7, 2009. Consignees were informed of the affected product and instructed to work with local sales representatives in identifying any unused devices and arrange for return to the firm. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LIT
- Quantity affected
- 26
- Distribution
- Nationwide Distribution -- IL, FL, CA, WA, AL, OH, NY, MA, TX and IN.
- Date initiated
- 2009-05-06
- Date posted
- 2010-03-22
- Date terminated
- 2012-03-30
- 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 |
|---|---|---|
| VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER (K072798) | Abbott Vascular-Vascular Solutions | 2008-01-31 |