American Contract Systems recalls ARTHROSCOPY PACK-Procedure Kit (Catalog TNAR22V) 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 their ARTHROSCOPY PACK-Procedure Kit (Catalog Number TNAR22V) 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 device is used for extended periods without proper cleaning.
The cast padding in the ARTHROSCOPY PACK-Procedure Kit contains ethylene oxide and ethylene chlorohydrin residues that exceed safe exposure limits. These chemicals can cause tissue damage if the padding remains in contact with the body for extended periods without proper cleaning.
This recall affects medical professionals and patients who use the ARTHROSCOPY PACK-Procedure Kit for surgical procedures. Patients with prolonged use of the cast padding may be at higher risk of tissue damage.
Check for the catalog number TNAR22V on the ARTHROSCOPY PACK-Procedure Kit. The kit was sold with lot numbers starting with 978241. This product is used in medical procedures involving joint surgery.
The cast padding may contain ethylene oxide and ethylene chlorohydrin residues exceeding safe levels for long-term use.
The product may contain ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term use, potentially causing tissue damage.
Look for the catalog number TNAR22V on the ARTHROSCOPY PACK-Procedure Kit, which was sold with lot numbers starting with 978241.
The recall does not specify a remedy, so contact American Contract Systems for guidance on safe handling or disposal.
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-2304-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2304-2024 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.
