FDA-Device2025-03-26Class II
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
American Contract Systems Inc
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.
Sold states
US Nationwide distribution in the state of OH.
Affected count
90 kits
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1339-2025Don't want to check this manually?
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