Data Foundry

Medical device recalls 2019

BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part… — Class II medical device recall Z-2279-2019

Terminated recall by Becton Dickinson & Company, reported 2019-08-21, distributed nationwide. Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additiv

Recall numberZ-2279-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Company, Franklin Lakes, NJ, United States
Recall initiated2019-05-30
Classified2019-08-14
Reported by FDA2019-08-21
Terminated2020-05-05
DistributedNationwide (US)
Countries outside the USCA
Quantity247,000 tubes
UPC / GTIN / UDI-DI30382903670018
Lot numbers2020/7/31, 8187663
Model numbers367001

Product

BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations

Reason for recall

Lot has been confirmed to have no additive within the tube. Sample processed without the preservative (additive) in the tube, testing has yielded reliable results if the samples were stored at room temperature for no longer than two days. If the sample was stored for more than 2 days, the result for blood alcohol determination might not be accurate (either falsely low or falsely high)

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-2279-2019. 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.