Z-0270-06

Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable...

Name: Z-0270-06 Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable...
Creator: Wilson-Cook Medical Inc
Published: 2005-10-31
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2005-10-31 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of 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'' *... on 2005-10-31. The reason FDA records is "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". 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-0270-06
Status: Terminated
Initiated: 2005-10-31
Posted: 2005-12-07
Terminated: 2007-06-07
Recalling firm: Wilson-Cook Medical Inc.
Product: 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
Product code: FGY Cannula, Injection
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter on/about 11/04/2005.
Quantity in commerce: 1045 units
Distribution: 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.
Product codes and lots: Lot number: W2073307, W2073308, W2074626, W2074627, W2074628, W2074629, W2074630, W2075126, W2075127, W2075128, W2075129, W2075130, W2076301, W2076302, W2076303, W2076304, W2076305, W2076306, W2076843, W2076844, W2076845, W2076846, W2076847, W2076848, W2076849, W2076850, W2076851, W2076852, W2076853, W2076854, W2076855, W2076856, W2076857, W2101351, W2103706, W2104274, W2104275, W2108267, W2108774, W2109312, W2109313, W2111333, W2114602, W2114603, W2116350, W2118471, W2121588, W2121589, W2122051, W2122052, W2122053, W2124537, W2125592, W2125593, W2125594, W2125595, W2129956, W2125597, W2129958

Product code FGY

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)