Z-1410-04

Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer...

Name: Z-1410-04 Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer...
Creator: Wilson-Cook Medical Inc
Published: 2003-01-30
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2003-01-30 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO... on 2003-01-30. The reason FDA records is "Label contains the 'Sterile EO' symbol, however the device is provided non-sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1410-04
Status: Terminated
Initiated: 2003-01-30
Posted: 2004-08-26
Terminated: 2005-03-04
Recalling firm: Wilson-Cook Medical Inc.
Product: 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
Product code: ESW Prosthesis, Esophageal
Reason for recall: Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by visit by personal company representative to the user facility on January 30, 2003.
Quantity in commerce: 5 units
Distribution: CT, HI, LA, MO, PA
Product codes and lots: Order Number EZSP-25-10-FC, Lot Number R1688574

Product code ESW

K920218Class IIEsophageal Z-StentWilson-Cook Medical, Inc. / cleared 1994-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)