Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use O
FDA device recall Z-0270-06 · posted 2005-12-07 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- 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.
- Action taken
- Consignees were notified by letter on/about 11/04/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGY
- Quantity affected
- 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
- Date initiated
- 2005-10-31
- Date posted
- 2005-12-07
- Date terminated
- 2007-06-07
- Location
- Winston Salem, NC
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