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)
FDA Recall Z-0135-2008 · Posted 2008-02-06
Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeDQX
Date Initiated2007-08-15
Date Terminated2008-04-21
Product Quantity33
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.
Firm Action
Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA, Australia, India, Trinidad and Tobago.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.