Recall Z-1410-04 ยท ESW Prosthesis, Esophageal
Wilson-Cook Medical Inc
Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
| Date | Aug 26, 2004 (initiated Jan 30, 2003) |
| Status | Terminated |
| Reason | Label contains the 'Sterile EO' symbol, however the device is provided non-sterile. |
| Root cause | Other |
| Action | Consignees were notified by visit by personal company representative to the user facility on January 30, 2003. |
| Quantity | 5 units |
| Distribution | CT, HI, LA, MO, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920218 | ESOPHAGEAL Z-STENT Wilson-Cook Medical, Inc., Feb 9, 1994 |