Recall Z-2258-2018— Becton Dickinson & Company

Name: FDA recall Z-2258-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-11

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2018-04-11, terminated 2019-05-10. It names one FDA 510(k) clearance: K013971. Product: The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.. Reason: 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%..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2018-04-11
Terminated: 2019-05-10
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K013971 — BD VACUTAINER SAFETY COAGULATION TUBEBecton, Dickinson & CO·cleared 2002-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

Reason for recall

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%.

Data sourced from openFDA. This site is unofficial and independent of the FDA.