Recalls / —
—#26519
Product
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-212
- FDA product code
- GBM — Catheter, Urethral
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K870694
- Affected lot / code info
- Lot Numbers: 5180479 5188907 5222243 5253537 5296860 5309467 5345287 5369860
Why it was recalled
Warning flag may be detached from the tip protector on thel catheter and result in the tip protector advancing through the catheter during use
Root cause (FDA determination)
Other
Action the firm took
Boston Scientific/Microvasive, Natick, MA notified domestic accounts by letter on 3/17/03. Users are requesed to check inventory and return product to Boston Scientific. A responsed form was requested to be completed. and returned by facsmile.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Boston Scientific Place, Natick, Massachusetts 01760
Distribution
- Distribution pattern
- Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
Timeline
- Recall initiated
- 2003-03-17
- Posted by FDA
- 2003-04-17
- Terminated
- 2016-03-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #26519. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.