Argon Medical Devices recalls TLAB liver biopsy kits with potential sheath separation during use, risking surgery. Affected units include specific lot numbers and models.
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, which could require surgery to prevent permanent damage. This is a serious medical risk for patients undergoing liver biopsies.
The sheath in the biopsy kit can separate if the tip is bent or flexed during use. This separation may cause permanent damage to the body or require surgery to fix the issue.
Patients who have received the recalled TLAB liver biopsy system kits from Argon Medical Devices are at risk. Healthcare providers using these kits for procedures are most vulnerable.
Check for the product name 'TLAB, Transjugular Liver Biopsy System' with model REF: TL - 18S and 1/18 GA Flexcore Biopsy Needle. Affected units have specific lot numbers: 1419196, 1460291, 1469844, 1502325.
Immediately stop using the recalled TLAB liver biopsy system kits as they can cause sheath separation leading to surgery.
The recalled product is Argon Medical Devices TLAB, Transjugular Liver Biopsy System with model REF: TL - 18S and 1/18 GA Flexcore Biopsy Needle.
Affected lot numbers are 1419196, 1460291, 1469844, and 1502325.
The recall record does not mention any remedy or replacement options.
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-1072-2021 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-1072-2021 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.
