RecallHawk
Class II Recall

SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERC

Argon Medical Devices, Inc

Summary

The FDA issued a Class II for SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BI by Argon Medical Devices, Inc. Reason: Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments..

Details

Source

Device Recall

External ID

Z-0354-2022

Action Date

2021-12-15

Status

Ongoing

Category

device

Product Description

SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; SC 1409/PGI Supercore 14GA x 9CM; SC 1609/PGI Supercore 16GA x 9CM; SC 1806/PGI Supercore 18GA x 6CM;

Lot/Code Info: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; Lot Numbers: 11364350 11365643 11368388 11371872 11374998 11376772 11378864 11382837 11385962 11389848 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; Lot Numbers: 11368389; 11376773; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; Lot Numbers: 11362716; 11363320; 11365935; 11377634; 11381340; 11384192; 11388461; 11388552; 11389139; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; Lot Numbers: 11361702; 11365788; 11371012; 11374235; 11376598; 11379722; 11382768; 11383890; 11388656; 11389138; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; Lot Numbers: 11362759; 11363229; 11364420; 11367439; 11370106; 11372917; 11376074; 11377430; 11378217; 11383193; 11383785; 11384243; 11387238; 11388864; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; Lot Numbers: 11370107; 11375663; 11377819; 11382602; 11385139; 11385965; 11389140; 11390503; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; Lot Numbers: 11372225; 11374410; 11377431; 11384193; 11388505; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; Lot Numbers: 11374411; 11378865; 11383280; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; Lot Numbers: 11366252 11367440; 11376374; 11377820; 11381387; 11385960; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; Lot Numbers: 11366253; 11380018; 11388893; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; Lot Numbers: 11369916; 11378293; 11383587; 11387065; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; Lot Numbers: 11377967; 11382843; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; Lot Numbers: 11364421; 11367443; 11374684; 11379724; 11385966; 11388551; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; Lot Numbers: 11382845; 11388550; 11390251; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; Lot Numbers: 11361701; 11364247; 11367445; 11372366; 11374807; 11378687; 11383192; 11383784; 11388286; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; Lot Numbers: 11371404; 11373084; 11377636; 11380993; 11383194; 11383195; 11387400; 11387833; 11390504; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; Lot Numbers: 11366315; 11372227; 11377432; 11381193; 11382998; 11384716; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; Lot Numbers: 11367446; 11370574; 11375664; 11380589; 11381572; 11388507; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; Lot Numbers: 11368750; 11371876; 11372228; 11376375; 11377429; 11380104; 11384717; 11387148; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; Lot Numbers: 11362655; 11363516; 11372322; 11378295; 11380103; 11382884; 11387584; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; Lot Numbers: 11371356; 11382375; 11389615; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; Lot Number: 11371357; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; Lot Number: 11371359; SC 1409/PGI Supercore 14GA x 9CM; Lot Numbers: 11370550; 11384881; SC 1609/PGI Supercore 16GA x 9CM; Lot Number: 11370552; SC 1806/PGI Supercore 18GA x 6CM; Lot Numbers: 11375600; 11364469;

Quantity Affected: 79,910 devices

Reason for Recall

Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of ALB, ARE, ARG, AUS, AUT, BEL, BGD, BRA, CAN, CHE, CHL, CHN, COL, CZE, DEU, ECU, ESP, EST, FRA, GBR, GRC, HKG, HUN, IND, IRN, ISR, ITA, JOR, JPN, MAR, MEX, MYS, NLD, NPL, NZL, PAK, PER, PHL, POL, PRT, SAU, SGP, SRB, THA, TUR, and TWN.

Type: Voluntary: Firm initiated

Recall Initiated: 2021-10-04

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 144 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-0354-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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