RecallHawk
Class II Recall

BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 3

Argon Medical Devices, Inc

Summary

The FDA issued a Class II for BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, by Argon Medical Devices, Inc. Reason: Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introd.

Details

Source

Device Recall

External ID

Z-3192-2024

Action Date

2024-10-02

Status

Ongoing

Category

device

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

Lot/Code Info: 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)

Quantity Affected: 95,430

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-07-02

Company

Argon Medical Devices, Inc

Athens, TX

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Argon Medical Devices, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Argon Medical Devices, Inc have FDA actions?

Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-3192-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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