Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable il
FDA device recall Z-1866-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
- Action taken
- Sales representatives were notified via telephone, and recall product advisory notices will be sent to all consignees on 05/09/2009. Contact a Regulatory Affairs representative at 408-754-2161 or 408-754-2000 should you have any questions.
- Root cause
- Other
- Status
- Terminated
- Product code
- FCS
- Quantity affected
- 4500
- Distribution
- Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland
- Date initiated
- 2008-05-09
- Date posted
- 2008-09-16
- Date terminated
- 2010-12-21
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER URETERAL ILLUMINATOR SYSTEM III (K982542) | Stryker Endoscopy | 1998-09-22 |