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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Antimicrobial Catheter

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 Class 2 Recall
Cook Antimicrobial Catheter
see related information
Date Posted March 16, 2007
Recall Status1 Terminated on December 05, 2007
Recall Number Z-0637-2007
Recall Event ID 37102
Premarket Notification
510(K) Number
K950118 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum® Glide® Antimicrobial Catheter with EZ--Pass® Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.
Code Information Lots 1794998 and 1793611.
Recalling Firm/
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
These catheters do not include the proximal sidehole as required by the specification.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were notified by phone on 1/2/07 and instructed to return the product.
Quantity in Commerce 100
Distribution Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North 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 = FOZ and Original Applicant = COOK, INC.
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