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Terminated

Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * Rx Only * Wilson-Cook Medical * GI Endoscope * 4900 Betharine Station * Winston-Salem, NC 27105

FDA Recall Z-0270-06 · Posted 2005-12-07

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFGY
Date Initiated2005-10-31
Date Terminated2007-06-07
Product Quantity1045 units

Reason for Recall

Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.

Firm Action

Consignees were notified by letter on/about 11/04/2005.

Root Cause

Other

Distribution Pattern

Nationwide, Argentina, Australia, Bahamas, Bolivia, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Denmark, Ecuador, Egypt, El Salvador, Guatemala, Holland, Hong Kong, India, Ireland, Israel, Korea, Malaysia, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Uruguay, Venezuela, and West Indies.

Official Source

View FDA Recall →

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

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