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Recall Observatory FDA recall evidence

Device product

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.

Z-0464-2013

June 08, 2012

Class II

Product summary

Firm
Merit Medical Systems, Inc.
Event
Event 62749
Status
Terminated
Classification
Class II
Quantity
83 packs
Official record key
device-enforcement:Z-0464-2013

Official wording

Reason: 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.

Code information: Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092

Distribution pattern: Nationwide distribution: US including states of: NE and SD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.