American Contract Systems recalls KNEE ARTHROSCOPY PACK-Procedure Kit (WEKA15B) 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 a KNEE ARTHROSCOPY PACK-Procedure Kit (catalog number WEKA15: B) because ethylene oxide/ethylene chlorohydrin residuals in the cast padding exceed safety limits. This could cause tissue damage if the kit is used for extended periods.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residuals that exceed safe levels for long-term exposure. This could lead to tissue damage if the kit is used for extended periods during surgical procedures.
Healthcare professionals using the KNEE ARTHROSCOPY PACK-Procedure Kit (WEKA15B) for surgical procedures are most at risk. Patients receiving the kit for knee arthroscopy may also be affected.
Check for the catalog number WEKA15B on the kit. The kit was sold with lot numbers 996241 and 960241. The UDI-DI code 00191072199379 is also associated with this recall.
Verify the catalog number WEKA15B and lot numbers 996241 or 960241 on the kit.
The recall is for potential tissue damage from prolonged use of the cast padding due to excessive ethylene oxide/ethylene chlorohydrin residuals, but it is not an immediate safety hazard.
Look for the catalog number WEKA15B and lot numbers 996241 or 960241 on the kit. The UDI-DI code 00191072199379 is also associated with this recall.
The recall does not specify a remedy, so check with American Contract Systems for further instructions.
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-2312-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2312-2024 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.
