Recalls / —
—#26518
Product
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-211
- FDA product code
- GBM — Catheter, Urethral
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K870694
- Affected lot / code info
- Lot Numbers: 5178119 5188905 5192526 5192527 5194308 5198455 5202075 5205549 5208875 5208878 5225910 5226327 5229088 5235251 5235252 5235253 5258360 5258361 5269990 5270281 5270281 5286299 5288682 5291571 5291572 5315936 5327922 5331374 5334829 5334830 5337023 5344015 5363071 5366442 5366443 5375808 5381688
Why it was recalled
Warning flag may be detached from the tip protector on the 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 #26518. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.