Argon Medical Devices recalls TLAB liver biopsy kits with potential sheath separation causing surgical intervention. Affected models include TL-19 with specific lot numbers. Contact for remedy details.
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 their TLAB liver biopsy system kits due to a risk that the sheath might separate during use if bent. This could require surgery to fix permanent damage to the liver or other organs.
The sheath in the biopsy kit can separate if bent or flexed during use. This separation might cause the need for surgery to prevent permanent damage to liver tissue or other body structures.
Healthcare professionals using the TLAB system for liver biopsies are most at risk. Patients undergoing these procedures may be affected if they use the recalled kits.
Check for the model number TL-19 with the specific lot numbers: 1428364, 1451428, or 1486448. The product includes a curved metal stiffener in the sheath.
Identify the lot number on the product packaging to confirm if it's affected.
Reach out to Argon Medical Devices for specific instructions on next steps.
Yes, the sheath could separate during use if bent, potentially requiring surgery to prevent permanent damage.
Check the lot number on the packaging. If it matches the affected numbers, contact Argon Medical Devices for instructions.
Look for the model number TL-19 with lot numbers 1428364, 1451428, or 1486448 on the packaging.
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-1073-2021 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-1073-2021 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.
