American Contract Systems Inc recalls OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
- Recall date
- February 6, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1359-2025
- FDA classification
- Class II
- Brand / firm
- American Contract Systems Inc
- Sold / distributed
- US Nationwide distribution in the state of OH.
Why it was recalled
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
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