American Contract Systems recalls three surgical kits due to potential over-sterilization with EO gas, which may cause damage. Affected kits include Arthroscopy, Knee, and Hand Packs with specific model and lot numbers.
Product was sterilized with a higher than specification EO concentration.
American Contract Systems is recalling three surgical kits—Arthroscopy, Knee, and Hand Packs—because they were sterilized with a higher than specified concentration of ethylene oxide gas. This could lead to damage to the kits or potential harm to users during medical procedures.
The kits were sterilized using a higher concentration of ethylene oxide gas than the manufacturer's specifications. This over-sterilization could cause the kits to become damaged or malfunction during surgical procedures, potentially affecting patient safety.
Medical professionals using these kits for surgeries are most at risk. The recall affects specific model numbers and production lots sold to hospitals and clinics.
Check for model numbers: LMAR15R (Arthroscopy Kit), LWKN46N (Knee Kit), FHHP63T (Hand Pack). Lot numbers 981221, 966221, and 966221 are also associated with these kits.
Identify the model number on the kit: LMAR15R for Arthroscopy, LWKN46N for Knee, or FHHP63T for Hand Pack.
Confirm the lot number matches 981221 for Arthroscopy, 966221 for Knee and Hand Packs.
The kits were sterilized with a higher than specified concentration of ethylene oxide gas, which could cause damage to the kits or affect their performance during surgery.
Check the model and lot numbers to see if your kit is affected. If it is, contact American Contract Systems for further instructions.
The recall is due to potential damage to the kits, which could affect surgical procedures. However, the risk to patients is low as this is a manufacturing issue, not a direct safety hazard.
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-1037-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1037-2022 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.
