FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.
This recall has been terminated (originally issued January 5, 2009).
- Company
- Cook Endoscopy
- Recall Initiated
- October 30, 2008
- Posted
- January 5, 2009
- Terminated
- April 7, 2009
- Recall Number
- Z-0325-2009
- Quantity
- 11
- Firm Location
- Winston Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The wire control port may have been omitted during manufacture.
Distribution
Ireland
Lot / Code Info
Lot number W2501093
Root Cause
Process control
Action Taken
Cook Ireland (distributor) was contacted via email on 10/30/08 and was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. A response sheet was attached. Recall status reports will be issued monthly. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Should you have any questions, please contact Cook Endoscopy Customer Quality Assurance Department at 1-336-744-0157.
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