medical Class II Updated 2025-03-26

American Contract Systems Inc recalls OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19A

Recalled Product

OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02


Hazard / Issue

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 00191072184450 00191072221070 Lots 921241 70-051173 70-052439
View official government recall

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