Recall Z-2277-2021 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
QURA S.R.L.
Spectrum Medical Quantum Standard heat exchanger
| Date | Aug 12, 2021 (initiated Mar 22, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| Action | The firm notified their consignee of the problem by email beginning on 02/18/2021. They issued a recall noticed on 03/22/2021 by email. |
| Quantity | 1088 units |
| Distribution | US Nationwide distribution in the state of South Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.