FDA Device recall Z-2277-2021
Spectrum Medical Quantum Standard heat exchanger
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Spectrum Medical Quantum Standard heat exchanger by Qura S R L, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2277-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-22 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qura S R L |
| Distribution | US |
Product
Spectrum Medical Quantum Standard heat exchanger
Reason
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.
Identifiers
| code_info | Batch Numbers: B000129, C000415, C000416, C000417 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.