Recall Z-3192-2024— Argon Medical Devices, Inc

Name: FDA recall Z-3192-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-02

Class II · Ongoing

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2024-07-02. It names 2 FDA 510(k) clearances: K982960, K904987. Product: BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X. Reason: Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis..

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-07-02
Firm location: Athens, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K982960 — MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENTMedical Device Technologies, Inc.·cleared 1998-09-23
K904987 — VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)Vibronics·cleared 1991-02-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X

Reason for recall

Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.

Data sourced from openFDA. This site is unofficial and independent of the FDA.