Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-212
FDA device recall Z-0738-03 · posted 2003-04-17 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Warning flag may be detached from the tip protector on thel catheter and result in the tip protector advancing through the catheter during use
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBM
- Quantity affected
- 47 boxes (20 units/box)
- Distribution
- Nationwide Foreign:Singapore, Japan, Korea, Canada, Africa
- Date initiated
- 2003-03-17
- Date posted
- 2003-04-17
- Date terminated
- 2016-03-07
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER (K870694) | Van-Tec, Inc. | 1987-03-10 |