Device recall

Z-0439-2024: CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

FDA device recall · Class II · CardioQuip, LLC

Key facts

Recall number (Z-number) Z-0439-2024
Recall event 93347
Product CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Product code DWC
Recalling firm CardioQuip, LLC
Recall class Class II
Status Open, Classified
510(k) numbers K102147
FEI number 3007899424

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)