American Contract Systems recalls AHAR50K arthroscopy packs due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing tissue damage with prolonged use.
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 AHAR50:0K arthroscopy packs because ethylene oxide and ethylene chlorohydrin residues in the cast padding exceed safe levels for long-term use. This could lead to tissue damage if the packs are used repeatedly without proper cleaning.
The cast padding in the AHAR50K packs contains ethylene oxide and ethylene chlorohydrin residues that exceed safe limits for permanent exposure devices. This can cause tissue damage if the packs are used repeatedly without proper cleaning, as indicated by ANSI/AAMI/ISO 10993-7 standards.
Medical professionals using the AHAR50K arthroscopy packs for surgical procedures are most at risk. Patients using these packs for cast padding may also be affected if the residues cause irritation.
Check for the catalog number AHAR50K on the procedure tray. The packs were sold with lot numbers 638231, 962241, and 898241. The product was distributed by American Contract Systems Inc.
Look for the catalog number AHAR50K on the procedure tray and lot numbers 638231, 962241, or 898241.
The cast padding in the AHAR50K packs contains ethylene oxide and ethylene chlorohydrin residues that exceed safe limits for permanent exposure devices, potentially causing tissue damage with repeated use.
The recall record does not specify a remedy, so no action is required beyond checking if your product matches the described details.
The product may pose a low risk of tissue damage if used repeatedly without proper cleaning, but the recall record does not specify a remedy.
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-2274-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2274-2024 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.
