Argon Medical Devices recalls specific liver biopsy kits due to potential sheath separation during use, risking surgical intervention. Affected units include certain lot numbers of the TLAB system.
Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.
Argon Medical Devices is recalling specific liver biopsy kits because a manufacturing error may cause the sheath to separate during use. This could require surgery to prevent permanent damage to the liver or other body structures.
The sheath in the biopsy kit can separate if the tip is bent or flexed during use. This separation might cause the need for surgery to fix permanent damage to the liver or other body parts.
Healthcare professionals using the recalled liver biopsy kits are most at risk. Patients undergoing procedures with these kits may face complications requiring surgery.
Check for the model 'TLAB, Transjugular Liver Biopsy System' with lot numbers 1439836, 1451430, or 1486441. The product includes a curved metal stiffener and tissue removal swabs.
Verify the lot number on the product label to confirm if it's affected.
Reach out to Argon Medical Devices for guidance on next steps if the product is recalled.
Yes, the sheath may separate during use, potentially requiring surgery to prevent permanent damage to the liver or body structures.
Check the product's lot number to see if it's affected. Contact Argon Medical Devices for further instructions.
Look for the model 'TLAB, Transjugular Liver Biopsy System' with lot numbers 1439836, 1451430, or 1486441.
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-1074-2021 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-1074-2021 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.
