Reported Dec 12, 2012 · Terminated
Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 12701 N Kingston Ave · Chester, VA · 23836-2700
Is this the product you have?
- Custom Procedural TraysMerit'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
- Lot codes and dates
Merit's Custom Total Hip PackK12T-05537Lot numbers T320054T331364T335090Merit's Total Knee PackK12T05538Lot numbers T320059T331365T335092
- Amount recalled
- 83 packs
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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