FDAClass IIDecember 27, 2023

CardioQuip Modular Cooler-Heater recall: Contamination

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

Why was CardioQuip Modular Cooler-Heater recalled?

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 00860000846110 /Lot #:11160294 and 11161110

Product
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Recalling firm
CardioQuip, LLC
Quantity
2 units
Distribution
US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
Recall date
December 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls