Medical DeviceOct 13, 2021
CardioQuip recall — FDA Z-0035-2022
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class IIFDA: OngoingCardioQuip, LLC
Recall history in this database
Classification mix: Class II: 5.
Medical DeviceOct 13, 2021
CardioQuip recall — FDA Z-0069-2022
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially…
Class IIFDA: OngoingCardioQuip, LLC
Medical DeviceOct 13, 2021
CardioQuip recall — FDA Z-0038-2022
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class IIFDA: OngoingCardioQuip, LLC
Medical DeviceOct 13, 2021
CardioQuip recall — FDA Z-0037-2022
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class IIFDA: OngoingCardioQuip, LLC
Medical DeviceOct 13, 2021
CardioQuip recall — FDA Z-0036-2022
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
Class IIFDA: OngoingCardioQuip, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies CardioQuip, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.