# FDA recall Z-0749-2021

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

## Product

Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803    For Angiography/angioplasty.    The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze

## 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-0749-2021
- **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-0749-2021

## Citation

> AI Analytics. FDA recall Z-0749-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0749-2021. Source: US FDA. Licensed CC0.

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