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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Event Detail

Event ID 62749
Product Type Devices
Status Ongoing
Recalling Firm Merit Medical Systems, Inc.
City Chester
State VA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide distribution: US including states of: NE and SD.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092 Class II Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. 83 packs Z-0464-2013