The Recall Desk
HighFDA (Devices)·Z-0456-2016·Announced 2015-12-30

BD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Stopper Defect

Becton Dickinson is recalling 4.8 million blood collection tubes because stoppers may not be fully inserted, posing a risk of blood exposure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (blood exposure/splatter) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Becton Dickinson & Company is recalling 4,835,000 units of BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. The recall affects Catalog (Ref) # 367856, Lot Number 5014806. These tubes are used in clinical laboratories to collect, transport, and process blood in a closed system for testing serum, plasma, or whole blood.

The recall was initiated because some tubes were manufactured with the stopper not fully inserted into the tube. This defect may result in the stopper popping off in a small number of instances, which could lead to blood exposure and, in some cases, blood splatter or spraying.

The affected products were distributed worldwide, including the United States, Canada, Indonesia, Malaysia, and South Korea. Users should stop using the affected tubes and contact Becton Dickinson & Company for further instructions.

The recalled product

Product
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
Affected units
4,835,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog (Ref) # 367856
  • Lot Number 5014806

Distribution

Distributed nationwide across the United States.