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
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- October 31, 2005
- Posted
- December 7, 2005
- Terminated
- June 7, 2007
- Recall Number
- Z-0270-06
- Quantity
- 1045 units
- Firm Location
- Winston Salem, NC
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.
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.
Lot / Code Info
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
Root Cause
Other
Action Taken
Consignees were notified by letter on/about 11/04/2005.