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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter Introducer

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 Class 2 Device Recall Catheter Introducersee related information
Date Initiated by FirmDecember 07, 2007
Date PostedApril 16, 2008
Recall Status1 Terminated 3 on April 15, 2008
Recall NumberZ-0904-2008
Recall Event ID 46151
Product Classification Catheter Introducer - Product Code DYB
ProductCatalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries. Cook Inc., Bloomington, IN 47404
Code Information Lot Number: F2121485. 
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
ActionCook 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 Commerce1,881 of total products
DistributionWorldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Total Product Life CycleTPLC 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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