# FDA recall Z-0751-2021

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2020-11-10.

## Product

Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105    For Angiography/angioplasty.  The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.

## Reason for recall

Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a  compromised sterile barrier.  This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.

## Distribution

US distribution to: KY, RI, and MD

## Key facts

- **Recall number:** Z-0751-2021
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-10
- **Report date:** 2021-01-06
- **Termination date:** 2022-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0751-2021

## Citation

> AI Analytics. FDA recall Z-0751-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0751-2021. Source: US FDA. Licensed CC0.

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