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U.S. Department of Health and Human Services

Class 2 Device Recall Locking biliary catheter.

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  Class 2 Device Recall Locking biliary catheter. see related information
Date Initiated by Firm November 07, 2008
Date Posted January 13, 2009
Recall Status1 Terminated 3 on August 05, 2009
Recall Number Z-0614-2009
Recall Event ID 50193
510(K)Number K063733  
Product Classification catheter - Product Code FGE
Product ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.
Code Information Lot numbers: G543419, G625228, and MR604366.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 Merit Pkwy
South Jordan UT 84095
For Additional Information Contact
801-208-4795
Manufacturer Reason
for Recall		 Biliary drainage catheter tips may separate from the catheter shaft after placement.
FDA Determined
Cause 2		 Other
Action Customers were notified by Merit representatives by phone or visit beginning 11/07/2008. They were to identify and quarantine any unused inventory and complete a Product Retrieval Form. For further information, call 800-356-3748 x 4929.
Quantity in Commerce 108 units
Distribution Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.
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 = FGE and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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