CardioQuip, LLC: Medical Device Recall in 2023 - (Recall #: Z-0438-2024)

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

Class II

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

UDI: (01)00860000846110/Serial Numbers: 11160203, 11160204, 11160315, 11160316, 11160317, 11160318, 11160319, 11160320, 11161109, 11161832, 11161836, 11161837, 11161838, 11161839, 11160216, 11160217, 11160218, 11160548, 11160549, 11160550, 11160103, 11160338, 11160339, 11160364, 11160365, 11160366, 11161117, 11161118, 11161827,11161828, 11161829, 11161942, 11161943, 11161944, 11161978, 11162016, 11162018, 11160461, 11160462, 11160463, 11160464, 11160465, 11160579, 11161487, 11161488, 11161489, 11161613, 11161692, 11161695, 11161701, 11161702, 11161696 11161627, 11162262, 11160298, 11160378, 11160380, 11160385, 11160386, 11160387, 11160388, 11160377, 11160379, 11160376, 11160439, 11160440, 11161458, 11161460, 11161815, 11161816, 11161817, 11161818, 11161819, 11161907, 11161916, 11162057, 11162078, 11162079, 11162080, 11160375, 11160083, 11160270, 11160271, 11161018, 11161024, 11161019, 11161023, 11161022, 11161020, 11161021, 11160553, 11160554, 11161143, 11161144, 11161147, 11162002, 11162008, 11162009, 11162010, 11162011, 11160277, 11160290, 11160391, 11160289, 11161667, 11161668, 11161669, 11161670, 11161972, 11161973, 11161294, 11162139, 11162141, 11162142, 11162143, 11162170, 11162171 11160031, 11161076, 11161077, 11161890, 11162128, 11162129, 11161187, 11161189, 11161193, 11161194, 11161545, 11161546, 11161547, 11161549, 11160024, 11160025, 11160027, 11160075, 11161126, 11160314, 11162053, 11162054 11160071 11161083, 11161084, 11161085, 11161086, 11161087, 11161088, 11161089, 11161090, 11161091, 11161092

US Distribution: TX, IN, IL, WI, FL, NJ, PA, KY, VA, WV, CT, CA, WA, AL, IA

Voluntary: Firm initiated