American Contract Systems recalls cysto packs with unvalidated sterilization cycles. Affected units have specific tray, lot, and serial numbers. Consumers should check their product details to determine if they are affected.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling various cysto packs that were exposed to multiple sterilization cycles without proper validation. This could lead to contamination or failure of the medical device during use, posing a risk to patients.
The cysto packs were sterilized multiple times without validation, which could cause the device to become contaminated or fail during medical use. This might lead to infection or improper function in patients.
Patients using cysto packs for medical procedures are most at risk. The recall affects specific units with unique tray, lot, and serial numbers.
Check the tray number, sterilization lot, lot number, and bag serial number on the cysto pack. Affected units include specific combinations like LSRCFHCYTURC, 2105051, 883211, 15142078.
Identify the tray number, sterilization lot, lot number, and bag serial number on your cysto pack to see if it matches the listed affected units.
The cysto packs were exposed to multiple sterilization cycles without validation, which could lead to contamination or failure during medical use.
Check the tray number, sterilization lot, lot number, and bag serial number on your cysto pack. Affected units have specific combinations listed in the recall notice.
The recall does not specify a remedy, so contact American Contract Systems for further instructions if you believe your product is affected.
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-1695-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1695-2022 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.
