American Contract Systems recalls knee arthroscopy procedure kits with catalog number QPKA35A 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 knee arthroscopy procedure kits (catalog number QPK: QPKA35A) 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 kit is used for extended periods without proper cleaning.
The cast padding in the kit contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for permanent exposure devices. This can cause tissue damage if the padding is used for extended periods without thorough cleaning, as indicated by the ANSI/AAMI/ISO 10993-7 standard.
Healthcare professionals using the knee arthroscopy procedure kit for surgical procedures are most at risk. Patients receiving the procedure with this kit may also be affected if the cast padding is not properly cleaned.
Check for the catalog number QPKA35A on the kit. The lot numbers range from 913241 and the UDI-DI is 00191072201119. This kit was sold for surgical procedures.
Verify the catalog number QPKA35A and lot numbers 913241 on the kit.
The recall is for healthcare professionals using the kit during surgery. Patients receiving the procedure with this kit may be at risk if the cast padding is not properly cleaned.
Look for the catalog number QPKA35A and lot numbers starting with 913241 on the kit. The UDI-DI is 00191072201119.
The recall does not specify a remedy, so no action is required beyond checking the kit details.
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-2292-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2292-2024 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.
