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CardioQuip, LLC Recall 93446

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

CardioQuip, LLC Recall 93446 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0566-2024
Event ID93446
Event DescriptionCardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Product TypeDevices
DistributionUS: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None
Quantity2 units
Recall ReasonThere is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
Device Classification20231227
Device Code InfoUDI: 00860000846110 /Lot #:11160294 and 11161110
Center Classification Date20231215
Recall Initiation Date20231024
Recalling FirmCardioQuip, LLC
Initial Notification Letter
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