FDA Recall
Terminated
Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544
Recall: Z-0551-03
·
Initiated January 29, 2003
Recall
- Recall Number
- Z-0551-03
- Event Number
- 25487
- Firm
- Boston Scientific Corporation
- FEI Number
- 3001451463
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 29, 2003
- Posted
- February 8, 2003
- Terminated
- March 10, 2004
- Address
- 1 Boston Scientific Place, Natick, MA, 01760
Description
Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544
Reason
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.
Distribution
Nationwide
Quantity
22 units