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American Contract Systems Inc recalls OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Recalled March 26, 2025 · FDA recall Z-1359-2025 · American Contract Systems
Hazard
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. · FDA Class II
Units
54 kits
Sold at
US Nationwide distribution in the state of OH.
Description
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Product
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Manufacturer(s)
American Contract Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →