QURA S.R.L.: Medical Device Recall in 2021 - (Recall #: Z-2277-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Spectrum Medical Quantum Standard heat exchanger

Product Classification:

Class II

Date Initiated: March 22, 2021

Date Posted: August 18, 2021

Recall Number: Z-2277-2021

Event ID: 88267

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.

Status: Terminated

Product Quantity: 1088 units

Code Information:

Batch Numbers: B000129, C000415, C000416, C000417

Distribution Pattern:

US Nationwide distribution in the state of South Carolina.

Voluntary or Mandated:

Voluntary: Firm initiated