The Recall Desk

FDA (Devices) recall action 93446

CardioQuip, LLC recalled 2 products on 2023-12-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-12-27
Critical
0
Units
6

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2023-12-27

    CardioQuip Modular Cooler-Heater Model MCH-1000(m) Recalled for Bacterial Contamination

    CardioQuip LLC is recalling 2 units of its Model MCH-1000(m) Modular Cooler-Heater due to potential bacterial contamination that could result in patient infection. The affected devices are distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

    Product
    CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2023-12-27

    CardioQuip Modular Cooler-Heater Device Recalled for Potential Bacterial Contamination

    CardioQuip is recalling the Modular Cooler-Heater (Model MCH-1000i) due to potential bacterial contamination that could cause patient infection. Four units were distributed in California, Texas, Pennsylvania, Washington, Ohio, and Nebraska.

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