Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0464-2013 |
| Classification | Class II |
| Code Info | Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092 |
| Product Distributed Qty | 83 packs |
| Reason For Recall | 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. |
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 | Letter |
| Distribution Pattern | Nationwide distribution: US including states of: NE and SD. |
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