BD Vacutainer K2 EDTA — Class II medical device recall Z-0456-2016
Terminated recall by Becton Dickinson & Company, reported 2015-12-30, distributed nationwide. Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper
| Recall number | Z-0456-2016 |
|---|---|
| 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 | 2015-11-17 |
| Classified | 2015-12-21 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, ID, KR, MY |
| Quantity | 4,835,000 units |
| Lot numbers | 5014806 |
| Model numbers | 367856, 5014806BD |
Product
BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: 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. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
Reason for recall
Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
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-0456-2016. 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.