Z-0301-04

Howell D.A.S.H. II Access System, Wire Guided Sphincterotome

Name: Z-0301-04 Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
Creator: Wilson-Cook Medical Inc
Published: 2003-12-17
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2003-12-17 / Terminated / root cause: manufacturing process

FDA source

Wilson-Cook Medical Inc began a recall of Howell D.A.S.H. II Access System, Wire Guided Sphincterotome on 2003-12-17. The reason FDA records is "Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0301-04
Status: Terminated
Initiated: 2003-12-17
Posted: 2004-01-07
Terminated: 2004-04-16
Recalling firm: Wilson-Cook Medical Inc.
Product: Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by letter sent via Certified Mail on December 17, 2003.
Quantity in commerce: 18 units
Distribution: Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.
Product codes and lots: Reorder Number: DASH-35-480, Lot Number: W1815864

Product code KNS

K901443Class IIZimmon PapillotomeWilson-Cook Medical, Inc. / cleared 1990-06-18

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)