| | Class 2 Device Recall SuperCoreTM SemiAutomatic Biopsy Instrument |  |
| Date Initiated by Firm | October 04, 2021 |
|---|
| Create Date | December 09, 2021 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0354-2022 |
|---|
| Recall Event ID |
88814 |
| 510(K)Number | K974814 |
|---|
| Product Classification |
Instrument, biopsy - Product Code KNW
|
| 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; |
|---|
| Code Information |
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; |
Recalling Firm/
Manufacturer |
Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
|
| For Additional Information Contact | Rebecca Ellis
(469) -731-1410 |
|---|
Manufacturer Reason
for Recall | Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| 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 Brian.Rogers@argonmedical.com, or contact Arbee Cummings at Arbee.Cummings@argonmedical.com or Andrea Wieczor at Andrea.Wieczor@argonmedical.com.
(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).
|
|---|
| Quantity in Commerce | 79,910 devices |
|---|
| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KNW
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