medical Class II Updated 2023-10-18

LivaNova Deutschland GmbH recalls 3T Heater Cooler System, REF: 16-02-85

Recalled Product

3T Heater Cooler System, REF: 16-02-85


Hazard / Issue

The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322, 20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407, 20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387, 20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552, 20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347, 20T31361, 20T31365
View official government recall

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