Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.
FDA device recall Z-0377-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Cook Urological, Inc.
- Reason for recall
- Lack of assurance of sterility, as the packages may not have been sealed.
- Action taken
- Consignees were notified via recall letter dated 1/5/07 and requested to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FED
- Quantity affected
- 4
- Distribution
- Massachusetts, Maine, New Hampshire and Puerto Rico.
- Date initiated
- 2007-01-05
- Date posted
- 2007-01-25
- Date terminated
- 2008-05-01
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH (K043418) | Cook Urological, Inc. | 2005-03-31 |