FDA-Device2012-12-12Class II
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 Medical Systems, Inc.
Hazard
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.
Sold states
Nationwide distribution: US including states of: NE and SD.
Affected count
83 packs
Manufactured in
12701 N Kingston Ave, N/A, Chester, VA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2013Don't want to check this manually?
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