Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1074-2021 — Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,

U.S. FDA — Device Enforcement · United States · 2020-12-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1074-2021
Date of alert
2020-12-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Argon Medical Devices, Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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