Phlebotomy Blood Collection Kit
FDA product code OFM · Class II (moderate risk) · 21 CFR 870.2750 · Cardiovascular
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.
0510(k) clearances
0PMA approvals
3recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3181-2026 | Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs…Blood culture convenience kits contain a component subject to a drug recall that due to an an open or… | Medical Action Industries, Inc. 306 | 07/23/2026Open, Classified |
| Z-1558-2021 Class I | Kit: Blood Culture. MAI Kit Part Number: 80315DMedical convenience kits are being recalled due to a potential breach in the package integrity of a… | Medical Action Industries, Inc. 306 | 04/09/2021Terminated |
| Z-0894-2011 | Blood Center Kit w/Chloraprep One-Step, Sterile/Disposable/Single Patient Use, Reorder…Continental Medical labs, Inc, is recalling various lots of Blood Center Kit and Port VAD Kits because… | Continental Medical Labs,Inc | 12/06/2010Terminated |