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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 Recall
Boston Scientific/Microvasive
see related information
Date Posted February 08, 2003
Recall Status1 Open
Recall Number Z-0551-03
Recall Event ID 25487
Product Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544
Code Information Lot Number: 5173906
Recalling Firm/
Boston Scientific Corporation
1 Boston Scientific Place
Natick, Massachusetts 01760
For Additional Information Contact Robert T. Miragliuolo
Manufacturer Reason
for Recall
Breach in sterile barrrier may compromise sterility
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55