Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product
FDA device recall Z-0358-2011 · posted 2010-11-15 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.
- Action taken
- Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers. Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific. Customers can contact Boston Scientific at 510 624-1734.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KRA
- Distribution
- Distribution Worldwide, including throughout the US.
- Date initiated
- 2009-08-24
- Date posted
- 2010-11-15
- Date terminated
- 2011-02-03
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENEGADE FIBER BRAIDED MICROCATHETER (K973645) | Boston Scientific Corp | 1997-11-19 |