BD Vacutainer PLUS K2EDTA Tubes — Class II medical device recall Z-0571-2016
Terminated recall by Becton Dickinson & Company, reported 2016-01-06, distributed nationwide. Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insuffi
| Recall number | Z-0571-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2015-12-03 |
| Classified | 2015-12-31 |
| Reported by FDA | 2016-01-06 |
| Terminated | 2018-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, JP, KR |
| Quantity | 29,815,600 units |
| Lot numbers | 5089771, 5089820, 5154624, 5187753 |
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 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.
Reason for recall
Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0571-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.