ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394
FDA device recall Z-1063-03 · posted 2003-07-29 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Sterility of the device may b e compromised due to a lack of package integrity
- Action taken
- Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 2505 units
- Distribution
- Nationwide
- Date initiated
- 2003-07-03
- Date posted
- 2003-07-29
- Date terminated
- 2004-06-17
- Location
- Natick, MA
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