Merit Medical Systems Recalls Custom Procedural Trays Due to Missing Tape
Merit Medical Systems is recalling 83 custom procedural trays because clear protective tape was not applied during manufacturing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a protective barrier failed, creating a risk of exposure to patient fluids. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling 83 packs of Merit's Custom Total Hip Pack (K12T-05537) and Merit's Total Knee Pack (K12T05538). The affected lots are T320054, T331364, T335090 for the hip packs and T320059, T331365, T335092 for the knee packs.
The recall is due to a manufacturing defect where clear tape intended to prevent patient fluids from contacting the surgeon or surgical staff through the sleeve seam of the Stryker Hytrel Togas was not applied. This defect compromises the barrier function of the protective drapes.
The products were distributed nationwide, including in Nebraska and South Dakota. Healthcare facilities should stop using the affected trays and contact Merit Medical Systems for further instructions.
The recalled product
- 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 prod
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Drapes
- Affected units
- 83
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
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