Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Sing
FDA device recall Z-1410-04 · posted 2004-08-26 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
- Action taken
- Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- ESW
- Quantity affected
- 5 units
- Distribution
- CT, HI, LA, MO, PA
- Date initiated
- 2003-01-30
- Date posted
- 2004-08-26
- Date terminated
- 2005-03-04
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ESOPHAGEAL Z-STENT (K920218) | Wilson-Cook Medical, Inc. | 1994-02-09 |