Needle, Biopsy, Cardiovascular
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
103 adverse event reports on file
- ULTRACORE BIOPSY NEEDLE 18GA X 16CMDec 12, 2024InjuryArgon Medical Devices0001625425-2024-01170
- ULTRACORE BIOPSY NEEDLE 18GA X 16CMDec 12, 2024InjuryArgon Medical Devices0001625425-2024-01171
- OSTEO-SITEDec 3, 2024MalfunctionIzi Medical ProductsMW5163103
- ULTRACORE BIOPSY NEEDLE 18GA X 16CMNov 11, 2024MalfunctionArgon Medical Devices0001625425-2024-01131
- ULTRACORE BIOPSY NEEDLE 18GA X 16CMOct 28, 2024InjuryArgon Medical Devices0001625425-2024-01126
- ULTRACORE BIOPSY NEEDLE 18GA X 16CMOct 8, 2024MalfunctionArgon Medical Devices0001625425-2024-01116
- OSTEO-SITE BONE BIOPSY NEEDLEDec 14, 2018MalfunctionCook Inc1820334-2018-03718
- OSTEO-SITE BONE BIOPSY NEEDLE SETDec 14, 2018MalfunctionCook Inc1820334-2018-03719
- OSTEO-SITE BONE BIOPSY NEEDLEAug 6, 2018InjuryCook Inc1820334-2018-02201
- OSTEO-SITE BONE BIOPSY NEEDLEJul 25, 2018InjuryCook Inc1820334-2018-02075
Event type breakdown
Recalls
9 recall events for this product code
- Mermaid Medical A/STerminatedJul 22, 2015
Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single pa
Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.
Z-2190-2015 · View FDA record ↗ - Angiotech (Manan Medical Products, Inc.)TerminatedUnknown
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Z-0814-2019 · View FDA record ↗ - Angiotech (Manan Medical Products, Inc.)TerminatedUnknown
J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Z-0815-2019 · View FDA record ↗ - Angiotech (Manan Medical Products, Inc.)TerminatedUnknown
J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Z-0816-2019 · View FDA record ↗ - Angiotech (Manan Medical Products, Inc.)TerminatedUnknown
Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Z-0817-2019 · View FDA record ↗ - Angiotech (Manan Medical Products, Inc.)TerminatedUnknown
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Z-0818-2019 · View FDA record ↗ - Angiotech (Manan Medical Products, Inc.)TerminatedUnknown
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Z-0819-2019 · View FDA record ↗ - Angiotech (Manan Medical Products, Inc.)TerminatedUnknown
Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Z-0820-2019 · View FDA record ↗ - M.D.L. S.r.l.TerminatedUnknown
Bone Marrow Transplantation biopsy needle
Sterility assurance may be compromised.
Z-2489-2021 · View FDA record ↗
Registered firms
49 firms currently registered for this product code
Histo S.a.
VILLA RAFFO Buenos Aires, AR
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Sterigenics Us Llc
Grand Prairie, TX, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Aspen Surgical Products, Inc.
Caledonia, MI, US
Novo Surgical, Inc.
Westmont, IL, US
Acheron Instruments (pvt.) Ltd.
LAHORE Punjab, PK
Bauer Und Haselbarth-chirurg Gmbh
ELLERAU Schleswig-Holstein, DE
Unimed S.a.
ECUBLENS Vaud, CH
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Teleflex Medical Llc
Morrisville, NC, US
Vehu Medical Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Sabin Corporation
Blmgtn, IN, US
Surgicon Pvt Ltd
Sialkot Punjab, PK
Phoenix Instruments, Inc.
Lisle, IL, US
Wexler Surgical, Inc.
HOUSTON, TX, US
M.d.l. S.r.l.
Delebio (So) Sondrio, IT
Hilbro International (pvt) Limited
SIALKOT Punjab, PK
Steris Deutschland Gmbh
Wurmlingen Baden-Wurttemberg, DE
Teleflex Llc (nadc)
Olive Branch, MS, US
Argon Medical Devices Inc.
ATHENS, TX, US
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
510(k) clearances
11 clearances for this product code
- Vlv Associates, Inc.Feb 15, 1994
K933364 · PROMED BIOPSY NEEDLE
- Medical Device Technologies, Inc.Jun 19, 1992
K921418 · ULTRA-CORE BIOPSY NEEDLES
- Hart Enterprises, Inc.Oct 30, 1991
K913815 · AUTOMATED BIOPSY DEVICE, MODIFICATION
- Manan Medical Products, Inc.Apr 11, 1989
K890925 · MANAN BONE MARROW BIOPSY NEEDLE
- Medsurg Industries, Inc.Mar 14, 1989
K885145 · MEDSURG GREENE NEEDLE
- Hart Enterprises, Inc.Jan 26, 1989
K885149 · NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE
- Ocean Medical Products, Ltd.Jun 15, 1988
K882013 · SOFT TISSUE BIOPSY DEVICE
- Angiomed U.S., Inc.Dec 2, 1987
K874585 · ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE