Bone Marrow Biopsy Tray
General, Plastic Surgery · 21 CFR 878.4800
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- 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-3029-2024 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0531-2023 · View FDA record ↗ - Stradis Medical, LLC dba Stradis HealthcareOpen, ClassifiedDec 14, 2022
HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Z-0532-2023 · View FDA record ↗
Registered firms
16 firms currently registered for this product code
Centurion Medical Products, Lp
HOWELL, MI, US
Cg Bio Co., Ltd.
Hwaseong-si Gyeonggi, KR
Isomedix Operations Inc.
Northborough, MA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Isomedix Operations Inc
El Paso, TX, US
Shanghai Lange Medtech Co., Ltd.
Shanghai, CN
Cardinal Health 200, Llc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Vygon Mfg
DOVER, NH, US
Vygon Usa
Lansdale, PA, US
Custom Interventional Pain Management
San Antonio, TX, US
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations Inc
EL PASO, TX, US
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics Us Llc
Grand Prairie, TX, US
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.