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U.S. Department of Health and Human Services

Class 2 Device Recall Fusion OMNI

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  Class 2 Device Recall Fusion OMNI see related information
Date Initiated by Firm October 05, 2006
Date Posted November 08, 2006
Recall Status1 Terminated 3 on December 15, 2006
Recall Number Z-0160-2007
Recall Event ID 36516
510(K)Number K932205  
Product Classification ERCP catheter - Product Code KOG
Product Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Code Information Lot number W2243511, Expiration date 7/12/2009
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
800-245-4707
Manufacturer Reason
for Recall		 Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
FDA Determined
Cause 2		 Process control
Action Cook Ireland customers were notified by letter via email on 10/13/2006.
Quantity in Commerce 20 units
Distribution Worldwide.
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 = KOG and Original Applicant = WILSON-COOK MEDICAL, INC.
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