Bd Integra Syringe

• • Terminated Z-0619-2009 FDA Unclassified (pre-2012) ·initiated 24 Nov 2008 ·on shared 510(k) K023752

  Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.

• • Terminated Z-0582-2007 FDA Unclassified (pre-2012) ·initiated 27 Jan 2007

  The needle becomes detached from the hub/syringe

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

510(k) Number

K023752 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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