Phlebotomy Blood Collection Kit
Cardiovascular · 21 CFR 870.2750
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
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Medical Action Industries, Inc. 306TerminatedMay 12, 2021
Kit: Blood Culture. MAI Kit Part Number: 80315D
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Z-1558-2021 · View FDA record ↗ - Continental Medical Labs,IncTerminatedJan 11, 2011
Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder No. Q921CL, Manufactured for : Blood Center of Wisconsin, Milwaukee, WI.
Continental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because Covidien reported that testing could not pick up an Over-Sulfated Chondroitin Sulfate (OSCS) contaminant in the purified heparin sodium USP.
Z-0894-2011 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
Medical Action Industries, Inc. 306
ARDEN, NC, US
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Grand Prairie, TX, US
Cardinal Health 200, Llc
El Paso, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Nuo Therapeutics, Inc.
Houston, TX, US
Midwest Sterilization Corp.
JACKSON, MO, US
Isomedix Operations Inc
El Paso, TX, US
Printcraft Press
Idaho Falls, ID, US
Path-tec
Midland, GA, US
Trinity Sterile, Inc.
SALISBURY, MD, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Biomet, Inc.
WARSAW, IN, US
Midwest Sterilization Corp.
LAREDO, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Innovate Medical, Llc
Johnson City, TN, US
Labcorp Genetics
San Francisco, CA, US
Cardinal Health 200, Llc
Waukegan, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.