Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUS
FDA device recall Z-0840-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- Vance Products Incorporated
- Reason for recall
- The bond may break where the two materials meet, resulting in separation of the stent.
- Action taken
- Consignees were notified via "Urgent: Recall Notice" letter dated 7/31/08. The letter described the failure, instructed that the products be isolated and returned to the firm. For additional information, contact Cook Urological at 1-812-339-2235, ext. 7241.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FAD
- Quantity affected
- 1739 of all products.
- Distribution
- Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
- Date initiated
- 2008-07-31
- Date posted
- 2009-01-23
- Date terminated
- 2009-11-27
- 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 |
|---|---|---|
| AQ HYDROPHILIC STENT (K961446) | Cook Urological, Inc. | 1996-05-28 |