TLC Retractor and Single Step Pelvic Drape (contains 1 Product Code 820-175) Product Code: 820-177
FDA device recall Z-0259-06 · posted 2005-12-01 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Sterility of device compromised due to breach in packaging
- Action taken
- Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAD
- Quantity affected
- 310
- Distribution
- Nationwide
- Date initiated
- 2005-10-25
- Date posted
- 2005-12-01
- Date terminated
- 2007-06-20
- Location
- Natick, MA
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