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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific/Microvasive

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  Class 2 Device Recall Boston Scientific/Microvasive see related information
Date Initiated by Firm January 29, 2003
Date Posted February 08, 2003
Recall Status1 Terminated 3 on March 10, 2004
Recall Number Z-0551-03
Recall Event ID 25487
510(K)Number K970052  
Product Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon
Catalog # 4544
Code Information Lot Number: 5173906
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
For Additional Information Contact Robert T. Miragliuolo
508-652-5186
Manufacturer Reason
for Recall		 Breach in sterile barrrier may compromise sterility
FDA Determined
Cause 2		 Other
Action Boston Scientific/Microvasive, Natick, MA initiated a voluntary recall by letter dated 1/27/03, and mailed 1/29/03. Accounts were requested to remove affected lots and return product to Boston Scientific. A verification form was provided to monitor effectiveness of the recall notification. Non-reponders will be recontacted.
Quantity in Commerce 22 units
Distribution Nationwide
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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