American Contract Systems recalls knee arthroscopy packs with catalog number MEKA12R due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing tissue damage.
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
American Contract Systems is recalling knee arthroscopy packs with catalog number MEKA12R because ethylene oxide and ethylene chlorohy:drin residuals in the cast padding exceed safety limits. This could cause tissue damage if used improperly.
The cast padding in these knee arthroscopy packs contains higher-than-safe levels of ethylene oxide and ethylene chlorohydrin residues. These chemicals can cause tissue damage if the pack is used for permanent exposure, such as in long-term medical treatments.
Patients who received knee arthroscopy packs with catalog number MEKA12R from American Contract Systems are most at risk. Healthcare providers using these packs for medical procedures may also be affected.
Check for catalog number MEKA12R on the pack. The lot numbers 659231 and 978241 are also associated with this recall.
Look for catalog number MEKA12R and lot numbers 659231 or 978241 on the knee arthroscopy pack.
The recall indicates that ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceed safety limits, so it is not safe for use as intended.
The recall does not specify a remedy, so you should check with American Contract Systems for guidance on safe handling or disposal.
Check for catalog number MEKA12R and lot numbers 659231 or 978241 on the knee arthroscopy pack.
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-2291-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2291-2024 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.
