Bd Single Lumen Needle, Syringe and Blood Collection Set

• • Terminated Z-0588-2021 FDA Class II ·initiated 18 Nov 2020

  BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.

• • Terminated Z-0207-2018 FDA Class II ·initiated 31 May 2017

  Hub damage resulting in breakage and/or leakage during use.

• • Terminated Z-1009-2012 FDA Unclassified (pre-2012) ·initiated 8 Oct 2011

  Becton Dickinson has identified clogged needles.

510(k) Number

K021475 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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