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Recall Observatory FDA recall evidence

Device product

The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

Z-2260-2018

April 11, 2018

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 79901
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2260-2018

Official wording

Reason: Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.

Code information: All lots

Distribution pattern: US/PR-All 50 states and PR Global-AR, BO, BR, BS, BZ, CA, CO, CR, CW, DO, EC, GT, GY, IN, JM, JP, KR, MX, NI, PA, PE, SG, SR, SV, TT, TW, UY, VI Dates of distribution: June 2, 2017 to the present.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Approximately 3.4% of BD Vacutainer Plus Plastic Citrate Blood Collection Tubes (2.7mL) (light blue top tube) will exhibit over fill draw volumes from ~11-14%.