Open Heart A Pack (American Contract) – sterilization uncertainty (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Brand
American Contract Systems Inc
Lot Codes / Batch Numbers
UDI-DI 00191072184450 00191072221070 Lots 921241 70-051173 70-052439
Products Sold
UDI-DI 00191072184450 00191072221070 Lots 921241 70-051173 70-052439
American Contract Systems Inc is recalling OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 due to ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Recommended Action
Per FDA guidance
The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026