Recall of ENT Packs with unvalidated sterilization cycles. Affected units have specific tray, lot, and serial numbers. Stop using if you own these items to prevent potential contamination.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling ENT Packs that were exposed to multiple sterilization cycles without proper validation. This could lead to contamination risks if the packs are used after sterilization.
The packs were sterilized multiple times without proper validation, which could lead to contamination. This risk is present if the packs are used after being exposed to unvalidated sterilization cycles.
Healthcare professionals and facilities using ENT Packs with the listed tray numbers, sterilization lots, and serial numbers are affected. Those handling the packs without validated sterilization cycles face the highest risk.
Check the tray number, sterilization lot, lot number, and bag serial number on the ENT Packs. Affected units include specific combinations like LSRHPENTLHA, 2106181, 838211, 14882942.
Verify the tray number, sterilization lot, lot number, and bag serial number on the ENT Packs to confirm if they are affected.
The ENT Packs were exposed to multiple sterilization cycles without proper validation, which could lead to contamination risks.
Check the tray number, sterilization lot, lot number, and bag serial number. Affected units include specific combinations like LSRHPENTLHA, 2106181, 838211, 14882942.
The recall record does not specify a remedy, so contact American Contract Systems for further instructions.
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-1693-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1693-2022 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.
