Argon Medical Devices recalls TLAB liver biopsy kits with potential sheath separation during use, risking surgical intervention. Affected models include TL-19S with 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 liver biopsy kits that may separate during use, potentially requiring surgery to prevent permanent damage. This recall affects specific model numbers and lot ranges.
The biopsy kit's sheath may separate if the tip is bent or flexed during use. This separation could cause permanent damage to body structures or functions, requiring surgery to fix.
Medical professionals using the TLAB liver biopsy system with the specified model and lot numbers are most at risk. Patients undergoing procedures with these kits could face surgical intervention.
Check for the model 'TL - 19S' with the 1/19 GA Flexcore Biopsy Needle and 1/7F. Affected lots include 1439835, 1451429, and 1486445.
Identify the model number and lot numbers to confirm if your kit is affected.
The sheath in the biopsy kit may separate if the tip is bent or flexed during use, potentially requiring surgery to prevent permanent damage.
Affected models include TL - 19S with 1/19 GA Flexcore Biopsy Needle and 1/7F. Affected lots are 1439835, 1451429, and 1486445.
Check the model and lot numbers to see if your kit is affected. If it is, contact Argon Medical Devices 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-1075-2021 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-1075-2021 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.
