# FDA recall Z-0403-2022

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2021-12-01.

## Product

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

## Reason for recall

There is a probable mislabeling of product.  A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

## Distribution

US Nationwide distribution in the states of IL and NC.

## Key facts

- **Recall number:** Z-0403-2022
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-01
- **Report date:** 2021-12-29
- **Termination date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2022

## Citation

> AI Analytics. FDA recall Z-0403-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0403-2022. Source: US FDA. Licensed CC0.

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