BD Vacutainer K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA 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 treatment delay) without reported illness or injury, 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 specific lots of BD Vacutainer PLUS K2EDTA Tubes (Plastic) due to a manufacturing defect. The recall involves 29,815,600 units in total, distributed worldwide, including the United States, the European Union, the People's Republic of China, Japan, and the Republic of Korea. The affected products are identified by Catalog Reference #367844 (Lot 5154624), #367862 (Lots 5089771 and 5187753), and #368021 (Lot 5089820).
The recall was initiated because some of the blood collection tubes in these lots were manufactured with insufficient EDTA additive. These tubes are used to collect, transport, and process blood in a closed system for testing serum, plasma, or whole blood in clinical laboratories, as well as for routine immunohematology testing and blood donor screening.
The insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment. The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed and follow instructions from the manufacturer or regulatory authorities regarding the return or disposal of these products.
The recalled product
- Product
- BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg 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 (4)
- Catalog Reference #367844
- Lot number 5154624 Catalog Reference #367862
- Lot numbers 5089771 and 5187753 Catalog Reference #368021
- Lot number 5089820
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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