Z-0565-2024Class II

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

Name: Z-0565-2024 CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Creator: CardioQuip, LLC
Published: 2023-10-24
License: https://open.fda.gov/license/

CardioQuip / initiated 2023-10-24 / Open, Classified / root cause: manufacturing process

FDA source

CardioQuip, LLC began a recall of CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A on 2023-10-24. FDA classified it as Class II and gives the reason as "There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0565-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-24
Posted: 2023-12-15
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 the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 24, 2023, CardioQuip issued a "Urgent: Medical Device Correction/Removal" notification via USPS to all affected consignees. CardioQuip ask consignees to take the following actions: 1. CardioQuip recommends that you remove your potentially contaminated MCH device from service immediately. 2. CardioQuip Customer Service will contact you by November 3, 2023 to provide your facility with a loaner device and to schedule an IWPR procedure for your MCH device. 3. Please complete and return the Receipt of Communication/Response Form attached to this letter to CardioQuip as soon as possible. 4. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program:
Quantity in commerce: 4 units
Distribution: US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
Product codes and lots: UDI: 00860000846103 /Lot #:10161316, 10161479, 10160241, 10161040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0565-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0565-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15
Z-0566-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15

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)