Recall Z-0756-2013— Becton Dickinson & Company

Name: FDA recall Z-0756-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-12

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2012-11-12, terminated 2013-09-06. It names one FDA 510(k) clearance: K013971. Product: BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL. Reason: 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..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2012-11-12
Terminated: 2013-09-06
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

BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

Reason for recall

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.

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