medical Class II Updated 2021-12-15

Argon Medical Devices, Inc recalls SuperCore Biopsy Instrument: REF/Product Description: 70

Recalled Product

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;

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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;
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