American Contract Systems recalls Essentia MAJ Laparotomy Std Pack (ESLT53B) due to humidity readings out of spec, potentially affecting sterilization assurance. No remedy specified in official notice.
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 Essentia MAJ Laparotomy Std Pack (ESLT53B) because humidity readings in one controlled environment area were out of specification. This could mean the product wasn't properly sterilized, which is critical for medical safety.
The kit's humidity readings were out of specification in a controlled environment area. This means the product's sterilization assurance might not have been met, potentially leading to unsterilized surgical instruments.
Healthcare professionals using this medical kit for laparotomy procedures are most at risk. Patients receiving surgery with this kit could be exposed to unsterilized instruments.
Look for the Essentia MAJ Laparotomy Std Pack (ESLT53B) with UDI-DI: 00191072218438 and lot number 2405102. The kit expires May 10, 2025.
Verify the UDI-DI number (00191072218438) and lot number (2405102) on the kit.
The manufacturer identified that humidity readings were out of specification in one controlled environment area, which may mean sterilization assurance wasn't met.
The official recall notice does not specify any remedy.
Look for the Essentia MAJ Laparotomy Std Pack (ESLT53B) with UDI-DI: 00191072218438 and lot number 2405102.
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-3240-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3240-2024 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.
