FDA-Device2025-03-26Class II
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
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
54 kits
Manufactured in
85 Shaffer Park Dr, N/A, Tiffin, OH, United States
Products
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1359-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief