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U.S. Department of Health and Human Services

Class 2 Device Recall PeelAway Introducer Set

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 Class 2 Recall
PeelAway Introducer Set
see related information
Date Posted April 16, 2008
Recall Status1 Terminated on April 15, 2008
Recall Number Z-0896-2008
Recall Event ID 46151
Product Classification Introducer, Catheter - Product Code DYB
Product Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
Code Information Lot Numbers: F2114474 and F2120414.
Recalling Firm/
Manufacturer
Cook, Inc.
750 Daniels Way
Bloomington, Indiana 47404-9120
Manufacturer Reason
for Recall
Packaging Problem: The peel-away sheath does not peel uniformly or completely.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Quantity in Commerce 1,881 of total products
Distribution Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
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.
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