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
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- January 30, 2003
- Posted
- August 26, 2004
- Terminated
- March 4, 2005
- Recall Number
- Z-1410-04
- Quantity
- 5 units
- Firm Location
- Winston Salem, NC
Reason for Recall
Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
Distribution
CT, HI, LA, MO, PA
Lot / Code Info
Order Number EZSP-25-10-FC, Lot Number R1688574
Root Cause
Other
Action Taken
Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.
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