Argon Medical Devices recalls TLAB liver biopsy kits with potential sheath separation during use, risking surgical intervention. Affected kits have specific lot numbers.
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 certain 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 inside the biopsy kit can separate if the needle tip bends or flexes during use. This separation might require surgery to fix or reverse permanent damage to the liver or other body structures.
Patients undergoing liver biopsies using the recalled TLAB systems are most at risk. Healthcare providers using these kits for medical procedures may also be affected.
Check for the product name 'Argon Medical Devices TLAB, Transjugular Liver Biopsy System' with specific lot numbers: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182.
Look for the lot numbers listed: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182.
Due to a manufacturing error, the sheath in the biopsy kit can separate during use if the needle tip bends or flexes, potentially requiring surgery to prevent permanent damage.
Check the lot number on your kit. If it matches the listed numbers (1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182), contact Argon Medical Devices for instructions.
The recall does not provide a specific fix. Affected kits should be checked and contacted for further instructions.
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-1076-2021 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-1076-2021 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.
