Recall Z-0135-2008 ยท DQX Wire, Guide, Catheter
Cook, Inc.
THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 47402 - not on label)
| Date | Feb 6, 2008 (initiated Aug 15, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product. |
| Quantity | 33 |
| Distribution | Worldwide Distribution - USA, Australia, India, Trinidad and Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K832178 | AMPLATZ HEPARIN COATED CATHETER Cook, Inc., Aug 12, 1983 |