American Contract Systems recalls PACEMAKER PACK SLCV01J medical kits due to potential sterilization issues from humidity problems. Affected kits may not meet sterilization standards.
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 a specific medical convenience kit because humidity issues in one area could mean it wasn't properly sterilized. This affects the safety of the kit for medical use.
The kit's humidity readings were out of specification in a controlled environment, which means the sterilization process might not have been completed properly. This could lead to unsterilized materials being used in medical procedures.
Medical professionals using the PACEMAKER PACK SLCV01J kit with the specific lot number 2405112 are most at risk. Patients receiving this kit could be exposed to unsterilized materials.
Check for the model SLCV01J and lot number 2405112 on the kit. The expiration date is May 11, 2025, but the recall is active regardless of expiration.
Look for the model SLCV01J and lot number 2405112 on the kit to confirm if it's affected.
The recall is because humidity readings were out of specification in one controlled environment area, which means sterilization assurance requirements might not have been met.
The official notice does not provide a remedy or fix for this specific issue.
Check for the model SLCV01J and lot number 2405112 on the kit. The expiration date is May 11, 2025, but the recall is active regardless of expiration.
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-3226-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3226-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
