Argon Medical Devices recalls 250 single-use hemostasis valves (7F-9F) due to potential sterility loss from incomplete pouch seals. Affected units sold with lot number 11232311.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Argon Medical Devices is recalling 250 single-use hemostasis valves that may have incomplete pouch seals, risking loss of sterility. This could lead to infections if the product is used without proper sterility.
The pouch seal on the valve may not form properly, allowing contaminants to enter the product. This could cause infections if the valve is used without adequate sterility.
Healthcare professionals using the hemostasis valves for medical procedures are most at risk. Patients receiving these valves during surgery could be affected if sterility is compromised.
Check for the product name 'Argon Medical Devices Hemostasis Valve, 7F-9F' on the label. The lot number 11232311 identifies affected units sold in boxes of 250 valves.
Look for the lot number 11232311 on the label to confirm if the valve is affected.
The product may have incomplete pouch seals, risking loss of sterility. Do not use if you have the lot number 11232311.
250 valves per box with lot number 11232311.
Check the product label for the lot number 11232311. If it matches, stop using it and contact Argon Medical Devices for guidance.
We’ve drafted a message you can send Argon Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-0294-2020 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-0294-2020 from Argon Medical Devices. 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.
