BD Vacutainer¿ K2 EDTA — Class II medical device recall Z-0968-2018
Terminated recall by Becton Dickinson & Company, reported 2018-03-21, distributed nationwide. A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an antico
| Recall number | Z-0968-2018 |
|---|---|
| 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 | 2017-08-29 |
| Classified | 2018-03-12 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-05-16 |
| Distributed | Nationwide (US) |
| Quantity | 8,494,000 |
| UPC / GTIN / UDI-DI | 30382903678410 |
| Lot numbers | 6279849 |
| Model numbers | 367841 |
Product
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Reason for recall
A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
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-0968-2018. 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.