CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
Modular Cooler-Heater recalled by CardioQuip
CardioQuip is recalling CardioQuip Modular Cooler-Heater, distributed in 15 states. The recall was initiated on 19 Oct 2023 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-0438-2024
- FDA event ID
- 93347
- Recalling firm
- CardioQuip, College Station, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Oct 2023
- FDA classified
- 1 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 19 Oct 2023 | Recall initiated by company | |
| 1 Dec 2023 | Classified by FDA | +43 days |
| 13 Dec 2023 | Published 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 a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Where it was distributed
US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
AlabamaCaliforniaConnecticutFloridaIowaIllinoisIndianaKentuckyNew JerseyPennsylvaniaTexasVirginiaWashingtonWisconsinWest Virginia
Questions about this recall
Is Modular Cooler-Heater recalled?
Yes. CardioQuip recalled Modular Cooler-Heater on 19 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0438-2024.
Why was it recalled?
There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Which lots are affected?
UDI: (01)00860000846110/Serial Numbers: 11160203, 11160204, 11160315, 11160316, 11160317, 11160318, 11160319, 11160320, 11161109, 11161832, 11161836, 11161837, 11161838, 11161839, 11160216, 11160217, 11160218, 11160548, 11160549, 11160550, 11160103, 11160338, 11160339, 11160364, 11160365, 11160366, 11161117, 11161118, 11161827,11161828, 11161829, 11161942, 11161943, 11161944, 11161978, 11162016, 11162018, 11160461, 11160462, 11160463, 11160464, 11160465, 11160579, 11161487, 11161488, 11161489, 11161613, 11161692, 11161695, 11161701, 11161702, 11161696 11161627, 11162262, 11160298, 11160378, 11160380, 11160385, 11160386, 11160387, 11160388, 11160377, 11160379, 11160376, 11160439, 11160440, 11161458, 11161460, 11161815, 11161816, 11161817, 11161818, 11161819, 11161907, 11161916, 11162057, 11162078, 11162079, 11162080, 11160375, 11160083, 11160270, 11160271, 11161018, 11161024, 11161019, 11161023, 11161022, 11161020, 11161021, 11160553, 11160554, 11161143, 11161144, 11161147, 11162002, 11162008, 11162009, 11162010, 11162011, 11160277, 11160290, 11160391, 11160289, 11161667, 11161668, 11161669, 11161670, 11161972, 11161973, 11161294, 11162139, 11162141, 11162142, 11162143, 11162170, 11162171 11160031, 11161076, 11161077, 11161890, 11162128, 11162129, 11161187, 11161189, 11161193, 11161194, 11161545, 11161546, 11161547, 11161549, 11160024, 11160025, 11160027, 11160075, 11161126, 11160314, 11162053, 11162054 11160071 11161083, 11161084, 11161085, 11161086, 11161087, 11161088, 11161089, 11161090, 11161091, 11161092
Where was it sold?
US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
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 1000(i), Standard Unit recalled by CardioQuip | CardioQuip | Processing Deviation | Nationwide |
| Device | CLASS II | Modular Cooler-Heater 1000(m),Compact Unit recalled by CardioQuip | CardioQuip | Processing Deviation | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |