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U.S. Department of Health and Human Services

Class 2 Device Recall Cook ATB Advance PTA Dilatation Catheter

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 Class 2 Recall
Cook ATB Advance PTA Dilatation Catheter
see related information
Date Posted March 29, 2007
Recall Status1 Terminated on May 29, 2007
Recall Number Z-0665-2007
Recall Event ID 37568
Premarket Notification
510(K) Number
K052036 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.
Code Information Lot 1820419.
Recalling Firm/
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120
Manufacturer Reason
for Recall
Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Consignees were notified via telephone on 2/28/07 and instructed to return the product.
Quantity in Commerce 20 units
Distribution Illinois, North Carolina and South Carolina.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = COOK, INC.
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