FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc: 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
- Recall number
- Z-0270-06
- 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
- Status
- Terminated
- Initiated
- 2005-10-31
- Posted
- 2005-12-07
- Terminated
- 2007-06-07
- Reason
- 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
- Other
- Action
- Consignees were notified by letter on/about 11/04/2005.
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGY
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28