Becton Dickinson & Company: Medical Device Recall in 2015 - (Recall #: Z-0456-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: 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. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.

Product Classification:

Class II

Date Initiated: November 17, 2015

Date Posted: December 30, 2015

Recall Number: Z-0456-2016

Event ID: 72700

Reason for Recall:

Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.

Status: Terminated

Product Quantity: 4,835,000 units

Code Information:

Catalog (Ref) # 367856; Lot Number 5014806

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated