Recall Z-1746-2017— Becton Dickinson & Company

Name: FDA recall Z-1746-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-16

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2017-03-16, terminated 2018-05-01. It names one FDA 510(k) clearance: K945952. Product: BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.. Reason: BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2017-03-16
Terminated: 2018-05-01
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K945952 — VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1995-01-18

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

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.

Reason for recall

BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

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