Z-0439-2024Class II

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

Name: Z-0439-2024 CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Creator: CardioQuip, LLC
Published: 2023-10-19
License: https://open.fda.gov/license/

CardioQuip / initiated 2023-10-19 / Open, Classified / root cause: design

FDA source

CardioQuip, LLC began a recall of CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A on 2023-10-19. FDA classified it as Class II and gives the reason as "There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0439-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-19
Posted: 2023-12-01
Recalling firm: CardioQuip
Product: CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/19/23, CardioQuip issued a "Urgent: Medical Device Correction" notification to all affected consignees. This notification was an update to the firm's May 22, 2023 communication. CardioQuip ask consignees to take the following actions: 1. Prime the MCH-1000(i) and MCH-1000(m) prior to each use. 2.Never operate the device dry (see communication for further details). 3. Design Changes to be implemented (see communication for further details). A. Relocation of the water Level Sensor (see communication for further details). B. Software Update (see communication for further details). 4. Please fill out and submit the receipt of understanding of the contents of this letter to CardioQuip within 5 business days or receipt. 5. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program: Phone: +1 (800) FDA-1088 Web: www.fda.gov/medwatch/report.htm
Quantity in commerce: 125 units
Distribution: US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA
Product codes and lots: UDI: (01)00860000846103/ Serial Numbers: Serial Numbers: 10160461, 10160463, 10160465, 10160466, 101060467, 10160468, 10161406, 10161408, 10161553, 10161689, 10160275 1016276, 1016277, 10160274, 10161065, 10161066, 10160825, 10160826, 10160827, 10160828, 10161140, 10161141, 10160830, 10160831, 10160832, 10160833, 10161543, 10160449, 10160450, 10160451, 10160452 , 1016050512, 10160513, 10160781, 10160785, 10160786, 10160787, 10160788, 10160789, 10160790, 10160791, 10160792, 10160793, 10160794, 10160795, 10161130, 10161131, 10161329, 10161517, 10160758, 10160094, 10160095, 10160096, 10160110, 10160113, 10160114, 10161294, 10161301, 10161303, 10161304, 10161306, 10160570, 10160572, 10160623 ,10160797, 10160798, 10160279, 10160280, 10160281, 10160282, 10161021, 10160797, 10161199, 10161200, 10161275, 10161343, 10161344, 10161560, 10161561, 10160824, 10160767, 10160097, 10160098, 10160099, 10160104, 10160105, 10160106, 10160108, 10160109, 10161043, 10161187, 10161679, 10161680, 10161681, 10160983, 10161830, 10160517, 10160519, 10160520, 10161312, 10160190, 10160191, 10160192, 10160193, 10160194, 10160248, 10160249, 10160250, 10160251, 10160967, 10160683, 10160684, 10160685, 10160686, 10160687, 10160688, 10160689, 10160690, 10161358, 10161359, 10161362, 10160084, 10160161, 10160183, 10161841

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0439-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0438-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0439-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code DWC

K102147Class IICardioquip Modular Cooler-Heater Model Mch-1000Cardioquip Llp / cleared 2010-11-19

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)