# FDA recall Z-2277-2021

> **QURA S.R.L.** · Class II · device recall initiated 2021-03-22.

## Product

Spectrum Medical Quantum Standard heat exchanger

## Reason for recall

Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.

## Distribution

US Nationwide distribution in the state of South Carolina.

## Key facts

- **Recall number:** Z-2277-2021
- **Recalling firm:** QURA S.R.L.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-22
- **Report date:** 2021-08-18
- **Termination date:** 2024-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mirandola, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2277-2021

## Citation

> AI Analytics. FDA recall Z-2277-2021. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2277-2021. Source: US FDA. Licensed CC0.

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