Z-3192-2024Class II

BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01...

Name: Z-3192-2024 BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01...
Creator: Argon Medical Devices, Inc
Published: 2024-07-02
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2024-07-02 / Open, Classified / root cause: packaging

FDA source

Argon Medical Devices, Inc began a recall of 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... on 2024-07-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3192-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-02
Posted: 2024-09-20
Recalling firm: Argon Medical Devices, Inc
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
Product code: KNW Instrument, Biopsy
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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: On 7/2/24, recall notices were mailed and emailed to Physician, Clinician, or Hospital Administrators who were asked to do the following: 1) Discontinue use of affected devices. 2) Segregate, quarantine, and return affected devices to the recalling firm. 3) Share this recall notice with the following parties to ensure your consignees receive a copy of this notice and the associated response form: a. Anyone who needs to be aware within your organization b. Any organization where the potentially affected products have been transferred or further distributed c. Anyone within your organization who may use this device 4) Complete and return the response form via email to [email protected]
Quantity in commerce: 95,430
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.
Product codes and lots: REF/Box UDI-DI/Unit UDI-DI/Lot(Expiration Date): 360-1080-01/20886333004373/00886333004379/11563436(22-Mar-2027), 11568010(16-Apr-2027), 11568790(1-May-2027), 11569552(7-May-2027), 11572560(20-May-2027) 360-1080-02/20886333224009/00886333224005/11563678(22-Mar-27), 11562475(05-Mar-27), 11562476(14-Mar-27), 11566932(08-Apr-27), 11567139(11-Apr-27), 11568361(16-Apr-27), 11569013(23-Apr-27), 11569844(29-Apr-27), 11571094(02-May-27), 11572044(08-May-27), 11572886(26-May-27); 360-1080-03/20886333224016/00886333224012/11569845(22-Apr-27), 11562477(04-Mar-27), 11564861(26-Mar-27), 11567888(12-Apr-27), 11568554(18-Apr-27), 11570075(04-May-27); 360-1580-01/20886333004359/00886333004355/11563438(21-Mar-2027), 11563439(19-Mar-2027); 360-1580-02/20886333224023/00886333224029/11562478(14-Mar-27), 11563440(18-Mar-27), 11563682(20-Mar-27), 11565238(03-Apr-27), 11566882(09-Apr-27), 11570132(01-May-27), 11570814(09-May-27), 11573339(20-May-27); 360-1580-03/20886333224030/00886333224036/11570288(02-May-27), 11563442(20-Mar-27), 11566173(03-Apr-27), 11566883(10-Apr-27), 11568153(16-Apr-27), 11570813(08-May-27); 360-2080-01/20886333004342/00886333004348/11563564(26-Mar-2027), 11566036(8-Apr-2027), 11567992(16-Apr-2027), 11570142(1-May-27), 11570863(8-May-27); 360-2080-02/20886333224047/00886333224043/11562964(07-Mar-27), 11563922(15-Mar-27), 11564189(22-Mar-27); 360-2080-03/20886333224054/00886333224050/11563443(15-Mar-27), 11566936(11-Apr-27), 11567889(22-Apr-2027); 370-1080-01/20886333004380/00886333004386/11564795(26-Mar-27); 370-1080-02/20886333224061/00886333224067/11562608(05-Mar-27), 11562748(04-Mar-27), 11564843(26-Mar-27), 11566037(08-Apr-27), 11571101(30-Apr-27), 11571360(06-May-27); 370-1080-03/20886333224078/00886333224074/11564844(22-Mar-27), 11566690(16-Apr-27), 11571100(01-May-27), 11573030(13-May-27); 370-1580-01/20886333004366/00886333004382/11564366(26-Mar-27); 370-1580-02/20886333224085/00886333224081/11571824(06-May-27), 11562114(07-Mar-27), 11566038(08-Apr-27), 11571824(06-May-27); 370-1580-03/20886333224092/00886333224098/11569414(22-Apr-27), 11571104(01-May-27); 763114100x/20886333006643/00886333006649/11563673(11-May-2029), 11570356(23-Apr-2029), 11571058(4-Apr-2029), 11572456(29-May-2029), 11572868(13-May-2029), 11573300(22-May-2029); 763116100X/20886333006612/00886333006618/11562815(7-Mar-2029), 11571061(29-Apr-2029); 763116160X/20886333006605/00886333006601/11571063(1-May-2029); 763118100X/20886333006582/00886333006588/11564330(26-Mar-2029); 763118200X/20886333006650/00886333006656/11562085(5-Mar-2029), 11571065(4-APR-2029); 763120100X/20886333006568/00886333006564/11564331(26-Mar-2029); 763120160X/20886333006575/00886333006571/11565618(10-Apr-2029); 763418200X/20886333006803/00886333006809/11566213(10-Apr-2029); 763418250X/20886333006810/00886333006816/11564594(22-Mar-2029), 11565619(4-Apr-2029), 11572175(22-May-2029); 763114200X/20886333006629/00886333006625/11566106(4-Apr-2029)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3192-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3192-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

Product code KNW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)