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Terminated

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

FDA Recall Z-0301-04 · Posted 2004-01-07

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeKNS
Date Initiated2003-12-17
Date Terminated2004-04-16
Product Quantity18 units

Reason for Recall

Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.

Firm Action

Consignees were notified by letter sent via Certified Mail on December 17, 2003.

Root Cause

Process control

Distribution Pattern

Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K901443ZIMMON PAPILLOTOMEWilson-Cook Medical, Inc. · 1990-06-18

Official Source

View FDA Recall →

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

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