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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
ReSolve		see related information
Date Posted February 20, 2013
Recall Number Z-0866-2013
Product Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Code Information Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095
For Additional Information Contact Mr. Paul Kennedy
801-208-4301
Reason for
Recall		 Merit Medical Systems is recalling certain lots of ReSolve Biliary Locking Drainage Catheters due to a consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Action Merit initiated the recall on January 16, 2013. A voicemail script notification to users and Q&A document was provided to those sales representative that had received and or distributed product. On January 16, 2013, Merit sales representatives began contacting each physician and/or user facility that had been provided product. Written communication distribution began on 22 January 2013. Affected sales representatives, physicians, and hospitals were provided written identification information, instruction to not distribute or continue placing these devices, and on how to return any unused product if applicable. All product on hand at Merit was inventoried and remains under quarantined status. Further questions please call (801) 208-4301,.
Quantity in Commerce 387 units
Distribution Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
 
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