Bd Vacutainer Safety Coagulation Tube

• 3 recalls, same reason

  • Terminated Z-2258-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2260-2018 FDA Class II ·initiated 11 Apr 2018
  • Terminated Z-2259-2018 FDA Class II ·initiated 11 Apr 2018

  Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.

• • Terminated Z-2633-2014 FDA Class II ·initiated 23 Jun 2014

  Products were held at improper storage temperature

• • Terminated Z-0756-2013 FDA Class II ·initiated 12 Nov 2012

  BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.

510(k) Number

K013971 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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