Class 2 Device Recall Cook Amplatz wire guide

• Date Initiated by Firm: August 15, 2007
• Date Posted: February 06, 2008
• Recall Status: Terminated on April 21, 2008
• Recall Number: Z-0135-2008
• Recall Event ID: 44879
• 510(K)Number: K832178
• Product Classification: Vascular Wire Guide - Product Code DQX
• Product: 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)
• Code Information: Lot E2026214.
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: 800-346-1686
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: Cook Incorporated notified consignees by Urgent Product Recall letter dated 8/15/07 instructing them to return the product.
• Quantity in Commerce: 33
• Distribution: Worldwide Distribution - USA, Australia, India, Trinidad and Tobago.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQX and Original Applicant = COOK, INC.