Becton Dickinson Syringe

• • Terminated Z-1577-2013 FDA Class II ·initiated 1 May 2013

  There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.

• • Terminated Z-1525-06 FDA Unclassified (pre-2012) ·initiated 24 Jul 2006

  BD received reports of needle assembly disengagement from the syringe.

• 4 recalls, same reason

  • Terminated Z-0404-06 FDA Unclassified (pre-2012) ·initiated 25 Oct 2005 ·on shared 510(k) K992734
  • Terminated Z-0405-06 FDA Unclassified (pre-2012) ·initiated 25 Oct 2005
  • Terminated Z-0403-06 FDA Unclassified (pre-2012) ·initiated 25 Oct 2005
  • Terminated Z-0402-06 FDA Unclassified (pre-2012) ·initiated 25 Oct 2005 ·on shared 510(k) K992734

  Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.

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

510(k) Number

K992734 ↗

FDA Product Code

MEG

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →