Agency classClass IIOur severity:High FDA (Devices)·Z-0036-2022·Announced 2021-10-13

CardioQuip Cooler-Heater Device Lacks Water-Quality and Inspection Guidance

FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. Missing maintenance guidance for a medical device used in healthcare settings constitutes a risk-of-harm situation even without reported adverse events, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CardioQuip Modular Cooler-Heater 1000(i) devices (Model MCH-10RMS, UDI 00860000846127) are subject to this FDA Class II recall. Approximately 1,380 units have been distributed worldwide, including across all U.S. states and territories, as well as Germany, The Bahamas, Panama, and Uruguay.

The devices' labeling fails to provide necessary guidance on proper water-quality maintenance and device inspection procedures. This omission prevents users from understanding critical operational requirements for maintaining device safety and performance.

Healthcare facilities and other users of affected devices should immediately contact CardioQuip, LLC to obtain proper maintenance and inspection guidance. Users should ensure they have comprehensive instructions for water-quality management and device inspection before continuing operation.

The recalled product

Product: CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Manufacturer: CardioQuip, LLC
Category: Medical Device — Heater-Cooler Device
Hazard: mis-labeling
missing-maintenance-guidance
Affected units: 1,380

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 4 recalled by CardioQuip, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · CardioQuip, LLC

See all →

High
CardioQuip Modular Cooler-Heater Model MCH-1000(m) Recalled for Bacterial Contamination
FDA (Devices) · 2023-12-27
High
CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination
FDA (Devices) · 2023-12-27
High
CardioQuip Modular Cooler-Heater heating chamber malfunction poses burn risk
FDA (Devices) · 2023-12-13
High
CardioQuip Modular Cooler-Heater Units Recalled for Heating Chamber Malfunction
FDA (Devices) · 2023-12-13
High
CardioQuip Modular Cooler-Heater Units Recalled for Bacterial Water Contamination
FDA (Devices) · 2021-10-13

Same hazard · mis labeling