FDA-Device2021-12-15Class II

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 BIOP

Argon Medical Devices, Inc
Hazard

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

Sold states
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.
Affected count
79,910 devices
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
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;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2022

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