Becton Dickinson Blunt Plastic Cannula

• • Terminated Z-1055-2015 FDA Class II ·initiated 19 Dec 2014 ·on shared 510(k) K974363

  The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.

• • Terminated Z-1461-06 FDA Unclassified (pre-2012) ·initiated 21 Jun 2006

  Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K974363 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →