CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

Modular Cooler-Heater recalled by CardioQuip

CardioQuip is recalling CardioQuip Modular Cooler-Heater, distributed in California, Nebraska, Ohio, Pennsylvania, Texas, Washington. The recall was initiated on 24 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00860000846110 /Lot #:11160294 and 11161110
Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0566-2024
FDA event ID
93446
Recalling firm
CardioQuip, College Station, TX
Classification
Class II
Status
Ongoing
Recall initiated
24 Oct 2023
FDA classified
15 Dec 2023
Reported
27 Dec 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

24 Oct 2023Recall initiated by company
15 Dec 2023Classified by FDA+52 days
27 Dec 2023Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

Product as listed by the FDA

CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A

Where it was distributed

US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None

CaliforniaNebraskaOhioPennsylvaniaTexasWashington

Questions about this recall

Is Modular Cooler-Heater recalled?

Yes. CardioQuip recalled Modular Cooler-Heater on 24 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0566-2024.

Why was it recalled?

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

Which lots are affected?

UDI: 00860000846110 /Lot #:11160294 and 11161110

Where was it sold?

US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CardioQuip

All 9
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIModular Cooler-Heater recalled by CardioQuipCardioQuipOther6 states
DeviceCLASS IIModular Cooler-Heater recalled by CardioQuipCardioQuipDevice Malfunction15 states
DeviceCLASS IIModular Cooler-Heater recalled by CardioQuipCardioQuipDevice Malfunction15 states
DeviceCLASS IIModular Cooler-Heater 1000(i), Standard Unit recalled by CardioQuipCardioQuipProcessing DeviationNationwide
DeviceCLASS IIModular Cooler-Heater 1000(m),Compact Unit recalled by CardioQuipCardioQuipProcessing DeviationNationwide

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