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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUSTICK II

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  Class 2 Device Recall ACCUSTICK II see related information
Date Initiated by Firm July 19, 2007
Date Posted December 07, 2007
Recall Status1 Terminated 3 on February 17, 2008
Recall Number Z-0328-2008
Recall Event ID 38471
510(K)Number K952828  
Product Classification Catheter Introducer - 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 IN 47460-1080
For Additional Information Contact
508-683-4433
Manufacturer Reason
for Recall		 Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
FDA Determined
Cause 2		 Process control
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 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.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = BOSTON SCIENTIFIC CORP.
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