Recall Z-0570-2016— Becton Dickinson & Company

Name: FDA recall Z-0570-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-03

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2015-12-03, terminated 2018-10-19. It names one FDA 510(k) clearance: K981013. Product: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.. Reason: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2015-12-03
Terminated: 2018-10-19
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K981013 — VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBEBecton Dickinson Vacutainer Systems·cleared 1998-06-17

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 PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.

Reason for recall

Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.

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