Recalls / —
—#42865
Product
Precision Twist Transvaginal Sling Kit with Non-Absorbable, Polybutester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-172
- FDA product code
- GAD — Retractor
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- All lots
Why it was recalled
Sterility of device compromised due to breach in packaging
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2005-10-25
- Posted by FDA
- 2005-12-01
- Terminated
- 2007-06-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #42865. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.