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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUSTICK II

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 Class 2 Recall
ACCUSTICK II
see related information
Date Posted December 07, 2007
Recall Status1 Open
Recall Number Z-0328-2008
Recall Event ID 38471
Product Classification Introducer, Catheter - Product Code DYB
Product Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760
Code Information Lot /Batch Number: 9498023.
Recalling Firm/
Manufacturer
Boston Scientific Corp
780 Brookside Dr
Spencer, Indiana 47460-1080
Manufacturer Reason
for Recall
Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
Action Consignees were notified via an Urgent Medical Device Recall Letter sent federal express on 7/19/07, which requested them to check their stocks, remove product from inventory, and return the product.
Quantity in Commerce 249 (199 U.S.A. plus 50 international)
Distribution Worldwide: USA and The Netherlands.
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
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