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.
What this means for you
Illness, injury, or structural failure has been reported. 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 testing
- Manufacturer
- Becton Dickinson & Company
- 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.
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