Agency classClass IIOur severity:Severe FDA (Devices)·Z-0569-2016·Announced 2016-01-06

BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive

Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because they may contain insufficient EDTA additive, which can lead to erroneous platelet results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall, and the source text explicitly states that the defect may lead to a delay of treatment, which aligns with the rubric criteria for a Severe rating involving significant injury or health risk.

Plain-English summary

Becton Dickinson & Company is recalling specific lots of BD Vacutainer PLUS K2EDTA Tubes (Plastic) due to a manufacturing defect. The affected tubes were manufactured with insufficient EDTA additive. The recall involves 29,815,600 units distributed worldwide, including the United States, the European Union, the People's Republic of China, Japan, and the Republic of Korea.

The FDA has classified this as a Class II recall. The insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. The affected products are identified by Catalog Reference #368054 (Lot numbers 5089827, 5210514, 5154646, 5210511) and Catalog Reference #367856 (Lot number 5064666).

Healthcare facilities and laboratories should check their inventory for these specific lot numbers and stop using the affected tubes. Users should contact Becton Dickinson for further instructions on how to handle the recalled products.

The recalled product

Product: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for…
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Blood Collection Tubes
Hazard: erroneous-results
delayed-treatment
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 (6)

Catalog Reference #368054
Lot numbers 5089827
5210514
5154646
5210511. Catalog Reference #367856
Lot number 5064666

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 →

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