Data Foundry

Medical device recalls 2019

BD Microtainer Tube w/ BD Microgard Closure — Class II medical device recall Z-1967-2019

Terminated recall by Becton Dickinson & Company, reported 2019-07-24, distributed in AL, CA, CT, FL, GA, IL, KY, MD…. The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may devel

Recall numberZ-1967-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Company, Franklin Lakes, NJ, United States
Recall initiated2019-06-03
Classified2019-07-12
Reported by FDA2019-07-24
Terminated2020-12-08
DistributedAL, CA, CT, FL, GA, IL, KY, MD, MN, MO, OH, PA, PR, TN, TX, VA
Quantity1,707,804
Lot numbers9017588, 9017590, 9017591, 9017592, 9017593, 9017596, 9017600, 9028803, 9045873, 9046822, 9050660, 9052823, 9056896
Model numbers365974, 365975

Product

BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive, Model Numbers 365974 and 365975 Product Usage: The Microtainer¿ Brand Tube with EDTA(K2) Reorder No. 365974, is used to collect, anticoagulate, transport and store skin puncture blood specimens for testing the following hematological parameters: WBC, RBC ,HGB, HCT, MCV, MCH, MCHC, Platelets, 5 part differential including : Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Manual WBC Differentials, Reticulocytes, and Spun Hematocrit.

Reason for recall

The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient 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-1967-2019. 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.