Z-0848-06

Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS...

Name: Z-0848-06 Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS...
Creator: Cook Endoscopy
Published: 2006-04-20
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2006-04-20 / Terminated / root cause: labeling and UDI

FDA source

Cook Endoscopy began a recall of Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 *... on 2006-04-20. The reason FDA records is "Large product label contains an incorrect expiration date". 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-0848-06
Status: Terminated
Initiated: 2006-04-20
Posted: 2006-05-06
Terminated: 2006-06-29
Recalling firm: Wilson-Cook Medical Inc.
Product: Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105
Product code: KOG
Reason for recall: Large product label contains an incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Consignees were notified by letter (USPS certified)on/about April 21, 2006.
Quantity in commerce: 43 units
Distribution: Alabama consignees
Product codes and lots: Lot: W2110292, Correct expiration on Small OEM Label: Mar-08, Expiration date on Large Label Apr-08; W2118663, Correct exp.: Mar-08, Exp. On large label: Apr-08; W2126166, Correct exp.: Apr-08, Exp. On large label: May-08; W2128638, Correct exp.: Apr-08, Exp. On large label: May-08; W2128639, Correct exp.: Apr-08, Exp. On large label: May-08; W2138018, Correct exp.: Apr-08, Exp. On large label: May-08; W2143643, Correct exp.: Apr-08, Exp. On large label: May-08; W2150003, Correct exp.: Apr-08, Exp. On large label: May-08; W2177983, Correct exp.: Apr-08, Exp. On large label: May-08; W2190096, Correct exp.: Sep-08, Exp. On large label: Oct-08; W2194318, Correct exp.: Sep-08, Exp. On large label: Oct-08.

Product code KOG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)