Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
FDA device recall Z-0177-2007 · posted 2006-11-14 · Terminated
Recall details
- Recalling firm
- Boston Scientific Target
- Reason for recall
- Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)
- Action taken
- On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 54 units
- Distribution
- Class III Recall-Worldwide-USA and Australia
- Date initiated
- 2006-10-13
- Date posted
- 2006-11-14
- Date terminated
- 2007-12-04
- 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 |