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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 Device Recall PeelAway Introducer set see related information
Date Initiated by Firm December 07, 2007
Date Posted April 16, 2008
Recall Status1 Terminated 3 on April 15, 2008
Recall Number Z-0897-2008
Recall Event ID 46151
Product Classification Catheter Introducer - Product Code DYB
Product Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Cook Inc., Bloomington, IN 47404.
Code Information Lot Number: F2143777.
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact
800-346-2686
Manufacturer Reason
for Recall		 Packaging Problem: The peel-away sheath does not peel uniformly or completely.
FDA Determined
Cause 2		 Package 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 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.
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