Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608

• • Terminated Z-0252-2020 FDA Class II ·initiated 7 Mar 2019

  BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

510(k) Number

K982541 ↗

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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