Tray, Surgical, Needle
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
68 adverse event reports on file
- SOFT TISSUE BIOPSY TRAYJun 22, 2026MalfunctionCarefusion, Inc1423507-2026-00091
- SOFT TISSUE BIOPSY TRAYJun 1, 2026MalfunctionCarefusion, Inc1423507-2026-00078
- ECONOMY SOFT TISSUE BIOPSY TRAYAug 1, 2025InjuryCarefusion, Inc1625685-2025-00077
- SAFETY SOFT TISSUE BIOPSY TRAYJun 25, 2025MalfunctionCarefusion, Inc1625685-2025-00058
- N/AJun 2, 2025MalfunctionCarefusion 2200, Inc22122550
- ECONOMY SOFT TISSUE BIOPSY TRAYNov 9, 2023MalfunctionCarefusion, Inc1625685-2023-00107
- JAMSHIDI NEEDLE BIOPSY 15G X 100MM DISPMay 20, 2022MalfunctionCarefusion, Inc1625685-2022-00055
- ILLINOIS NEEDLE BONE MARROW 15G ADJ LENJul 16, 2020InjuryCarefusion, Inc9680904-2020-00019
- ILLINOIS NEEDLE BONE MARROW 15G ADJ LEJan 31, 2020MalfunctionCarefusion, Inc9680904-2020-00003
- ILLINOIS NEEDLE BONE MARROW 15G ADJ LENNov 21, 2019MalfunctionCarefusion, Inc9680904-2019-00022
Event type breakdown
Recalls
7 recall events for this product code
- Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
4380 ECONOMY SOFT TISSUE BIOPSY TRAY
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2668-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3014-2024 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
The integrity of the sterile packaging is potentially compromised.
Z-1422-2018 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
The integrity of the sterile packaging is potentially compromised.
Z-1423-2018 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
The integrity of the sterile packaging is potentially compromised.
Z-1424-2018 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
The integrity of the sterile packaging is potentially compromised.
Z-1425-2018 · View FDA record ↗ - Carefusion 2200 IncTerminatedUnknown
Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
The integrity of the sterile packaging is potentially compromised.
Z-1426-2018 · View FDA record ↗
Registered firms
22 firms currently registered for this product code
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
C.r. Bard, Inc.
MADISON, GA, US
Carefusion 2200, Inc.
Vernon Hills, IL, US
Dongguan Shin Yi Healthcare Products Factory
DONG GUAN CITY Guangdong, CN
Sterigenics Us Llc
Charlotte, NC, US
Origami Surgical Inc.
Dover, MA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Carefusion 2200, Inc.
Mannford, OK, US
Cbr Enterprise Limited
Hong Kong, HK
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Mci Medical Concept Innovation Inc.
Sunrise, FL, US
Ortho-med, Inc.
Tigard, OR, US
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Comfort Surgical Instruments
Sialkot Punjab, PK
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Sterizign Precision Technologies
Brunswick, ME, US
Carefusion D.r. 203 Ltd.
SANTO DOMINGO Distrito Nacional, DO
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Midwest Sterilization Corp.
JACKSON, MO, US
Midwest Sterilization Corp.
LAREDO, TX, US
Palix Medical, Llc
Keyport, NJ, US
Sterigenics U.s., Llc
Santa Teresa, NM, US
510(k) clearances
8 clearances for this product code
- Carl Zeiss, Inc.Dec 15, 1988
K884876 · S 4 INSTRUMENT STAND
- Carl Zeiss, Inc.Sep 13, 1988
K883578 · S 21 INSTRUMENT STAND
- Emerson-Sack-Warner Corp.Jul 30, 1982
K821921 · STAND, SURG. INSTRUMENT & DRESSING
- American Pharmaseal Div. AhscJan 28, 1982
K813337 · SKINNY CHIBA NEEDLE & TRAY
- American Pharmaseal Div. AhscJan 28, 1982
K813338 · BIOPSY NEEDLES & TRAYS
- American Pharmaseal Div. AhscJan 8, 1982
K813335 · PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
- Applied Medical ResearchMay 19, 1978
K780759 · MODEL 902 STAND
- Diagnostic Products Corp.Dec 22, 1977
K772188 · FSH RIA KIT (125I)