Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
FDA device recall Z-0122-2007 · posted 2006-11-01 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04
- Action taken
- Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 5 units
- Distribution
- TX, KY
- Date initiated
- 2005-08-10
- Date posted
- 2006-11-01
- Date terminated
- 2012-05-16
- 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 |
|---|---|---|
| RENEGADE HI-FLO MICROCATHETER (K000177) | Boston Scientific Corp | 2000-04-07 |