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U.S. Department of Health and Human Services

Class 2 Device Recall ReSolve

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 Class 2 Recall
ReSolve
see related information
Date Posted February 20, 2013
Recall Status1 Open
Recall Number Z-0866-2013
Recall Event ID 64202
Premarket Notification
510(K) Number
K121832 
Product Classification Catheter, Biliary, Diagnostic - Product Code FGE
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
Manufacturer Reason
for Recall
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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