Reported Dec 30, 2015 · Terminated

BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect,…

Becton Dickinson & Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton Dickinson & Company · 1 Becton Dr · Franklin Lakes, NJ · 07417-1815

Is this the product you have?

  • BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes
  • Product UsageBD 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 generaltherefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions
Lot codes and dates
    • Catalog (Ref) # 367856
    • Lot Number 5014806
Amount recalled
4,835,000 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 8, 2016 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.