Recall of hysterectomy and vaginal packs from American Contract Systems due to potential exposure to multiple sterilization cycles without validation. Affected items have specific tray, lot, and serial numbers.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling various hysterectomy and vaginal packs that may have been exposed to multiple sterilization cycles without proper validation. This could lead to contamination or infection risks for patients using these medical devices.
The packs were sterilized multiple times without validation, meaning the sterilization process might not have been effective. This could result in the packs being contaminated with harmful bacteria or pathogens, posing infection risks during medical procedures.
Patients who received these specific hysterectomy or vaginal packs during surgery. Medical professionals using the packs for procedures are also at risk if they handled contaminated items.
Check the tray number, sterilization lot, lot number, and bag serial number on the pack. Affected items include specific combinations like LSRGYOSCOPYG (tray 2104281), LSRLMGLAPF (tray 2105282), and others listed in the recall notice.
Look for the tray number, sterilization lot, lot number, and bag serial number on the pack to determine if it's affected.
The packs were exposed to multiple sterilization cycles without validation, which could lead to contamination and infection risks.
Check the tray number, sterilization lot, lot number, and bag serial number on the pack. Affected items include specific combinations listed in the recall notice.
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-1702-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1702-2022 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.
