THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035
FDA device recall Z-0135-2008 · posted 2008-02-06 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.
- Action taken
- Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 33
- Distribution
- Worldwide Distribution - USA, Australia, India, Trinidad and Tobago.
- Date initiated
- 2007-08-15
- Date posted
- 2008-02-06
- Date terminated
- 2008-04-21
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPLATZ HEPARIN COATED CATHETER (K832178) | Cook, Inc. | 1983-08-12 |