Z-2277-2021Class II

Spectrum Medical Quantum Standard heat exchanger

Name: Z-2277-2021 Spectrum Medical Quantum Standard heat exchanger
Creator: Qura S.r.l.
Published: 2021-03-22
License: https://open.fda.gov/license/

Spectrum Medical Inc / initiated 2021-03-22 / Terminated / root cause: manufacturing process

FDA source

QURA S.R.L. began a recall of Spectrum Medical Quantum Standard heat exchanger on 2021-03-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2277-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-22
Posted: 2021-08-12
Terminated: 2024-04-22
Recalling firm: Spectrum Medical Inc
Product: Spectrum Medical Quantum Standard heat exchanger
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1088 units
Distribution: US Nationwide distribution in the state of South Carolina.
Product codes and lots: Batch Numbers: B000129, C000415, C000416, C000417

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2277-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2277-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code KFM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)