FDA Device

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

Hazard

Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.

What You Should Do

Remedy

Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.

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Products

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 Bethan
Brand
Wilson-Cook Medical Inc
UPC
Order Number EZSP-25-10-FC, Lot Number R1688574

Units Affected

5 units

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