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U.S. Department of Health and Human Services

Class 3 Device Recall Fusion OmniTome

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  Class 3 Device Recall Fusion OmniTome see related information
Date Initiated by Firm June 12, 2009
Date Posted July 21, 2009
Recall Status1 Terminated 3 on April 06, 2010
Recall Number Z-1598-2009
Recall Event ID 52283
510(K)Number K052051  
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
Product Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Code Information Product Order Number: FS-OMNI; Lot Number: W2454655.
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
336-744-0157
Manufacturer Reason
for Recall		 The wire control port of these devices may be missing due to omission of a manufacturing activity.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 20 units
Distribution International Distribution - Italy, Netherlands, Germany and Spain.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KNS and Original Applicant = WILSON-COOK MEDICAL, INC.
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