Vacuette Holdex

• • Terminated Z-2957-2011 FDA Unclassified (pre-2012) ·initiated 29 Jun 2011

  At removal of the tube from the holder, the needle may dislodge and blood spill can occur.

• 2 recalls, same reason

  • Terminated Z-2198-2008 FDA Unclassified (pre-2012) ·initiated 5 Aug 2008
  • Terminated Z-2134-2008 FDA Unclassified (pre-2012) ·initiated 16 May 2008

  At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.

510(k) Number

K980768 ↗

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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