Argon Medical Devices recalls specific liver biopsy kits due to risk of sheath separation during use, potentially requiring surgery to prevent permanent damage.
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 transjugular liver biopsy systems because a manufacturing error might cause the sheath to separate during use. This could lead to the need for 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 require surgery to prevent permanent damage to the liver or other body structures.
Patients undergoing liver biopsies using the recalled TLAB systems are most at risk. Healthcare providers who use these devices for medical procedures may also be affected.
Check for the product name 'Argon Medical Devices TLAB, Transjugular Liver Biopsy System' with the specific reference numbers: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F. The lot numbers listed are 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182.
Identify the product by checking the reference numbers and lot numbers listed in the recall notice.
The recall is due to a manufacturing error that may cause the sheath to separate during use, potentially requiring surgery to prevent permanent damage.
Check the product details against the reference numbers and lot numbers listed in the recall notice to determine if you have a recalled item.
The recall notice does not specify a remedy, so no immediate fix is provided.
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-1077-2021 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-1077-2021 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.
