Becton Dickinson & Company: Medical Device Recall in 2016 - (Recall #: Z-0570-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 3, 2015

Date Posted: January 6, 2016

Recall Number: Z-0570-2016

Event ID: 72868

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.

Status: Terminated

Product Quantity: 29,815,600 units in total

Code Information:

Catalog Reference #367855; Lot numbers 5064684, 5120653, 5154643, 5175930, 5210765, 5237787

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

Voluntary or Mandated:

Voluntary: Firm initiated