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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific/Microvasive

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  Class 3 Device Recall Boston Scientific/Microvasive see related information
Date Initiated by Firm June 26, 2003
Date Posted July 15, 2003
Recall Status1 Terminated 3 on April 21, 2005
Recall Number Z-1019-03
Recall Event ID 26644
510(K)Number K991056  
Product Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm
Catalog Number: 6557
Code Information Lot Number: 5404484
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
For Additional Information Contact Robert T. Miragliuolo
508-652-8144
Manufacturer Reason
for Recall		 Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
FDA Determined
Cause 2		 Other
Action Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability.
Quantity in Commerce 23 units
Distribution CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea
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 = and Original Applicant = BOSTON SCIENTIFIC CORP.
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