FDA Recall Open, Classified

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;

Recall: Z-0354-2022 · Initiated October 4, 2021

Recall

Recall Number: Z-0354-2022
Event Number: 88814
Firm: Argon Medical Devices, Inc
FEI Number: 1625425
Product Code: KNW
Status: Open, Classified
Root Cause: Device Design
Initiated: October 4, 2021
Address: 1445 Flat Creek Rd, Athens, TX, 75751-5002

Description

Reason

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

Action

On 09/30/2021, the firm sent an "Urgent-Product Recall Notice" letter to customers via US Postal Service Registered Mail informing them that the firm has received complaints regarding the semi-automatic Biopsy instrument coming apart during shipping or prior to use. According to the firm's investigation, the plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame. Customers are instructed to return all affected product to the Recalling Firm's Athens TX facility using RGA#26683, attention Andrea Wieczor. Mailing address is: RGA# 26683 Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 USA Att: Andrea Wieczor In addition, Customers are instructed to complete the response acknowledgement form included with the letter/email and return by fax, mail, or email as soon as possible. For questions. contact the Director, Post-Market Experience at email address [email protected], or contact Arbee Cummings at [email protected] or Andrea Wieczor at [email protected]. (Updated information 11/2/2021), on 10/28/2021, the firm sent an updated "Urgent-Product Recall Notice for Additional Lots" letter via mail informing customers that they are expanding the recall to additional lots (list on the Inventory Sheet attached to recall notice). Again the Recalling Firm is instructing customer to return the affected product (listed on the Inventory Sheet).

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.

Quantity

79,910 devices