Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number: 400-200
FDA device recall Z-0734-03 · 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 the 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
- 12 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 |
|---|---|---|
| OPEN ENDED URETERAL CATHETER (K830840) | Van-Tec, Inc. | 1983-04-06 |