CLASS II ONGOING Device recall · Reported 13 Oct 2021 · FDA Enforcement Report
Modular Cooler-Heater recalled by CardioQuip
CardioQuip is recalling CardioQuip, Modular Cooler-Heater, distributed nationwide in the US. The recall was initiated on 12 May 2021 and the FDA has classified it as Class II.
Check your package
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-0035-2022
- FDA event ID
- 88622
- Recalling firm
- CardioQuip, College Station, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 May 2021
- FDA classified
- 6 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 12 May 2021 | Recall initiated by company | |
| 6 Oct 2021 | Classified by FDA | +147 days |
| 13 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Modular Cooler-Heater recalled?
Yes. CardioQuip recalled Modular Cooler-Heater on 12 May 2021. The recall is Class II and its status is Ongoing. Recall number Z-0035-2022.
Why was it recalled?
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Which lots are affected?
All Serial numbers
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Germany, The Bahamas, Panama, Uruguay.
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Modular Cooler-Heater recalled by CardioQuip | CardioQuip | Other | 6 states |
| Device | CLASS II | Modular Cooler-Heater recalled by CardioQuip | CardioQuip | Other | 6 states |
| Device | CLASS II | Modular Cooler-Heater recalled by CardioQuip | CardioQuip | Device Malfunction | 15 states |
| Device | CLASS II | Modular Cooler-Heater recalled by CardioQuip | CardioQuip | Device Malfunction | 15 states |
| Device | CLASS II | Modular Cooler-Heater 1000(i), Standard Unit recalled by CardioQuip | CardioQuip | Processing Deviation | Nationwide |
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