Recall of laparoscopy packs with unvalidated sterilization cycles. Affected units have specific tray, lot, and serial numbers. Stop using immediately to prevent infection risks.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling various laparoscopy packs that were exposed to multiple sterilization cycles without proper validation. This could lead to infection risks if the packs are used in medical procedures.
The packs were sterilized multiple times without validation, meaning the sterilization process wasn't confirmed to be effective. This could allow harmful bacteria to remain, increasing infection risk during surgery.
Healthcare professionals using laparoscopy packs in surgical procedures are most at risk. Patients undergoing surgery with these packs may face infection risks.
Check for the tray number, sterilization lot, lot number, and bag serial number listed in the recall notice. Affected packs include specific combinations like LSRENDOSCOPH 2104281, 890211, 14887854.
Review the tray number, sterilization lot, lot number, and bag serial number on the pack to confirm if it matches the listed affected units.
The packs were exposed to multiple sterilization cycles without validation, which could allow harmful bacteria to remain and increase infection risk during surgery.
Check the tray number, sterilization lot, lot number, and bag serial number on the pack. Affected units include specific combinations like LSRENDOSCOPH 2104281, 890211, 14887854.
The recall does not specify a remedy, so contact American Contract Systems directly for guidance on next steps.
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-1694-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1694-2022 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.
