American Contract Systems recalls ARTHROSCOPY PACK-Procedure Kit (TNAR22U) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing skin irritation 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 ARTHROSC: Procedure Kits with catalog number TNAR22U because the cast padding may have harmful chemical residues. This could cause skin irritation if used for extended periods, especially in medical settings.
The cast padding in the kit may contain excessive ethylene oxide and ethylene chlorohydrin residues. These chemicals can cause skin irritation or allergic reactions with prolonged exposure, particularly in medical environments where the padding is used for extended periods.
Medical professionals using the ARTHROSCOPY PACK-Procedure Kit for surgeries or treatments are most at risk. Patients receiving the kit for procedures may also be affected if the cast padding is used long-term.
Check for the catalog number TNAR22U on the kit. The kit was sold with lot numbers starting with 665231. This product is used in medical procedures and may be found in hospitals or clinics.
Look for the catalog number TNAR22U and lot numbers starting with 665231 on the kit.
The product may contain harmful chemical residues that could cause skin irritation with prolonged use, so it is not recommended for continued use without checking the recall.
Check for the catalog number TNAR22U and lot numbers starting with 665231 on the kit.
The recall does not specify a remedy, so contact American Contract Systems 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-2303-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2303-2024 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.
