Recall Z-0035-2022— CardioQuip, LLC

Name: FDA recall Z-0035-2022
Creator: U.S. Food and Drug Administration
Published: 2021-05-12

Class II · Ongoing

Class II FDA medical device recall by CardioQuip, LLC, initiated 2021-05-12. It names one FDA 510(k) clearance: K102147. Product: CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103. Reason: Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices..

Recalling firm: CardioQuip, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-05-12
Firm location: College Station, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K102147 — CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp·cleared 2010-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103

Reason for recall

Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.