# FDA recall Z-3192-2024

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2024-07-02.

## 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 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.

## Distribution

Worldwide - US Nationwide distribution including in the states of AZ, FL, OH, NY, MO, CO, IL, NC, CA, AK, PA, MN, ND, TX, SC, AR, WI, OK, TN, KS, UT, NJ, VA, MA, KY, IN, AL, DE, MT, NE, WV, NV, HI, OR, WA, NH, LA, CT, MI, GA, MD, ID, MS, IA, RI, NM, VT and the countries of  ITA, TUN, ROU, LTU, BEL, GBR, CAN, TUR, POL, PAN, THA, PRT, TWN, AUT, NZL, AUS, BGR, MEX, CHE, NLD, PHL, PER, FRA, SGP, ZAF, CZE, EST, ESP, OMN, NPL, COL, PRI, ISR, JPN, KEN, BHR, ARE, CHN.

## Key facts

- **Recall number:** Z-3192-2024
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-02
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3192-2024

## Citation

> AI Analytics. FDA recall Z-3192-2024. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-3192-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*