CardioQuip, LLC Recall 93446
Description: CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
CardioQuip, LLC Recall 93446 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0566-2024 |
Event ID | 93446 |
Event Description | CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A |
Product Type | Devices |
Distribution | US: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: None |
Quantity | 2 units |
Recall Reason | There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection. |
Device Classification | 20231227 |
Device Code Info | UDI: 00860000846110 /Lot #:11160294 and 11161110 |
Center Classification Date | 20231215 |
Recall Initiation Date | 20231024 |
Recalling Firm | CardioQuip, LLC |
Initial Notification | Letter |
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