The Recall Desk
HighFDA (Devices)·Z-0567-2016·Announced 2016-01-06

BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA blood collection tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.

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 is classified as FDA Class II. The hazard involves a risk of harm (erroneous results or delay of treatment) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling 29,815,600 units of BD Vacutainer PLUS K2EDTA Tubes (Plastic), 13 x 75 mm x 2.0 mL (Pink). The affected products are identified by Catalog Reference #367842 and Lot numbers 5089731 and 5175923. These evacuated blood collection tubes are used to collect, transport, separate, and process blood.

The recall was initiated because some of the blood collection tubes in these lots were manufactured with insufficient EDTA additive. An insufficient amount of EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.

The affected products were distributed worldwide, including the United States (nationwide), the European Union, the People's Republic of China, Japan, and the Republic of Korea. Healthcare facilities and laboratories should check their inventory for the specific lot numbers and catalog reference listed above. Users should stop using the affected tubes and contact Becton Dickinson for further instructions or replacement.

The recalled product

Product
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 prov
Affected units
29,815,600

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 Reference #367842
  • Lot numbers 5089731 and 5175923

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →