Bd Vacutainer Push Button Blood Colection Set

• • Terminated Z-0193-2020 FDA Class II ·initiated 31 Jul 2019

  Separation of front and rear barrels upon activation of the safety feature that retracts the needle

• • Terminated Z-0816-2011 FDA Unclassified (pre-2012) ·initiated 5 Oct 2010

  There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub.

• 2 recalls, same reason

  • Terminated Z-0590-2008 FDA Unclassified (pre-2012) ·initiated 20 Nov 2007 ·via K011984, on the same 510(k)
  • Terminated Z-0589-2008 FDA Unclassified (pre-2012) ·initiated 20 Nov 2007 ·via K011984, on the same 510(k)

  Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.

• • Terminated Z-0034-2007 FDA Unclassified (pre-2012) ·initiated 11 Aug 2006 ·via K011984, on the same 510(k)

  A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.

• • Terminated Z-0372-06 FDA Unclassified (pre-2012) ·initiated 1 Dec 2005 ·via K011984, on the same 510(k)

  Cracked finger grip luer adapter components on the Push Button Blood Collection Set.

• • Terminated Z-0549-04 FDA Unclassified (pre-2012) ·initiated 17 Dec 2003 ·via K011984, on the same 510(k)

  A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K011984 ↗

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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