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U.S. Department of Health and Human Services

Class 2 Device Recall FSOMNI, Fusion OmniTome

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 Class 2 Device Recall FSOMNI, Fusion OmniTomesee related information
Date Initiated by FirmOctober 30, 2008
Date PostedJanuary 05, 2009
Recall Status1 Terminated 3 on April 07, 2009
Recall NumberZ-0325-2009
Recall Event ID 50118
510(K)NumberK052051 
Product Classification Endoscopic electrosurgical unit - Product Code KNS
ProductFS-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.
Code Information Lot number W2501093
FEI Number 1037905
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information ContactSharon Miles
336-744-0157
Manufacturer Reason
for Recall		The wire control port may have been omitted during manufacture.
FDA Determined
Cause 2		Process control
ActionCook 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.
Quantity in Commerce11
DistributionIreland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = KNS
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