American Contract Systems recalls OPEN HEART Adult Side A devices with specific model numbers due to potential sterilization issues that could cause treatment delays.
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 OPEN HEART Adult Side A devices with model numbers LLOH01I-01 and LLOH01I. The recall is because these devices might not have been properly sterilized, which could lead to treatment delays or complications.
The devices may not have been properly sterilized during manufacturing. This could lead to treatment delays or complications if the devices are used without proper sterilization.
Patients using the OPEN HEART Adult Side A devices with model numbers LLOH01I-0:1 and LLOH01I are affected. Medical professionals who use these devices for treatments are at risk of delays.
Check for model numbers LLOH01I-01 or LLOH01I on the device. The devices were sold with specific lot numbers 898241, 70-050704, and 70-051731.
Look for model numbers LLOH01I-01 or LLOH01I on the device.
The recall is because American Contract Systems is unable to confirm that the devices were properly sterilized, which could lead to treatment delays or complications.
The recall record does not specify a remedy, so there is no action required beyond checking if your device has the model numbers listed.
The recall indicates a possible risk of treatment delays or complications, but no specific health hazards are mentioned.
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-1339-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1339-2025 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.
