FDA recall Z-2277-2021

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

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

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