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Terminated

Spectrum Medical Quantum Standard heat exchanger

FDA Recall Z-2277-2021 · Posted 2021-08-12

Recalling FirmQURA S.R.L.
Recall StatusTerminated
Product CodeKFM
Date Initiated2021-03-22
Date Terminated2024-04-22
Product Quantity1088 units

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.

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

US Nationwide distribution in the state of South Carolina.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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