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Terminated

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

FDA Recall Z-1410-04 · Posted 2004-08-26

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeESW
Date Initiated2003-01-30
Date Terminated2005-03-04
Product Quantity5 units

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

CT, HI, LA, MO, PA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K920218ESOPHAGEAL Z-STENTWilson-Cook Medical, Inc. · 1994-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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