American Contract Systems recalls Pacemaker COPM11B medical kits due to humidity readings causing sterilization concerns. Affected units have specific lot and expiration dates.
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling Pacemaker COPM11B medical kits because humidity readings in one controlled area may mean the products weren't properly sterilized. This could affect medical safety if used without proper sterilization.
The humidity readings in one controlled environment area were out of specification, which means the product's sterilization process might not have been properly completed. This could lead to potential contamination if the kit is used without proper sterilization.
Medical professionals using the Pacemaker COPM11B kits with lot number 2405033 and expiration date 05/03/2025 are most at risk. Patients using these kits for medical procedures may be affected if sterilization was compromised.
Check for the lot number 2405033 and expiration date 05/03/2025 on the Pacemaker COPM11B medical kits. The product is sold under the brand American Contract Systems.
Look for lot number 2405033 and expiration date 05/03/2025 on the Pacemaker COPM11B medical kits.
American Contract Systems identified that humidity readings in one controlled environment area were out of specification, which may mean the product wasn't properly sterilized.
The official recall notice does not specify any action steps beyond checking the product details for the lot number and expiration date.
The recall indicates potential sterilization issues, but the official notice does not mention a risk of serious 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-3244-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3244-2024 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.
