Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
This recall has been terminated (originally issued July 21, 2009).
- Company
- Cook Endoscopy
- Recall Initiated
- June 12, 2009
- Posted
- July 21, 2009
- Terminated
- April 6, 2010
- Recall Number
- Z-1598-2009
- Quantity
- 20 units
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The wire control port of these devices may be missing due to omission of a manufacturing activity.
Distribution
International Distribution - Italy, Netherlands, Germany and Spain.
Lot / Code Info
Product Order Number: FS-OMNI; Lot Number: W2454655.
Root Cause
Process control
Action Taken
The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at cws.complaints@cookmedical.com or 1-336-744-0157.
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