Drug recall
Spectrum Medical Quantum Standard heat exchanger
FDA recall event 88267 · Class II · QURA S.R.L.
Key facts
| Event ID | 88267 |
|---|---|
| Recall numbers | Z-2277-2021 |
| Recalling firm | QURA S.R.L. |
| Product type | Devices |
| Products | Spectrum Medical Quantum Standard heat exchanger |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Mar 22, 2021 |
| Report date | Aug 18, 2021 |
| Termination date | Apr 22, 2024 |
| City | Mirandola |
| Country | Italy |
| FEI number | 3016746283 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: