American Contract Systems recalls OPEN HEART A PACK models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02 due to possible failure in sterilization assurance, which could delay or prolong medical treatment.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems is recalling certain OPEN HEART A PACK medical devices because they may not have been properly sterilized. This could cause delays or longer treatment times for patients using these devices.
The devices may not have met sterilization requirements, which could lead to contamination or improper function. This might cause treatment delays or longer procedures than intended.
Patients using the recalled OPEN HEART A PACK devices for medical procedures may be affected. Healthcare providers who use these devices are at risk of treatment delays.
Check for model numbers UTOH19AI, UTOH19AJ-01, or UTOH19AJ-02 on the device. The devices were sold with specific lot numbers: 921241, 70-051173, and 70-052439.
Look for model numbers UTOH19AI, UTOH19AJ-01, or UTOH19AJ-02 on the device.
The recall is due to possible failure in sterilization assurance, which could lead to delays or prolonged treatment.
The official recall notice does not specify a remedy or action steps beyond checking the model number.
The recall indicates a possible risk of treatment delays or longer procedures, but no immediate safety hazards like injury or death.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1359-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1359-2025 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
