Recall Z-0737-03 ยท GBM Catheter, Urethral
Boston Scientific Corporation
Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-211
| Date | Apr 17, 2003 (initiated Mar 17, 2003) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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. |
| Quantity | 267 boxes (20 units/box) |
| Distribution | Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870694 | VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER Van-Tec, Inc., Mar 10, 1987 |