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Terminated

Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

FDA Recall Z-0160-2007 · Posted 2006-11-08

Recalling FirmCook Endoscopy
Recall StatusTerminated
Product CodeKOG
Date Initiated2006-10-05
Date Terminated2006-12-15
Product Quantity20 units

Reason for Recall

Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.

Firm Action

Cook Ireland customers were notified by letter via email on 10/13/2006.

Root Cause

Process control

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932205ERCP CATHETER, HYDROPHILIC COATEDWilson-Cook Medical, Inc. · 1994-01-03

Official Source

View FDA Recall →

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

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