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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 64202
Product Type Devices
Status Ongoing
Recalling Firm Merit Medical Systems, Inc.
City South Jordan
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-16
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system. Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379. Class II 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. 387 units Z-0866-2013
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