Becton Dickinson & Company: Medical Device Recall in 2016 - (Recall #: Z-0567-2016)

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 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube.

Product Classification:

Class II

Date Initiated: December 3, 2015

Date Posted: January 6, 2016

Recall Number: Z-0567-2016

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 #367842; Lot numbers 5089731 and 5175923

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