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.
FDA Recall Z-2259-2018 · Posted None
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2018-04-11
Date Terminated2019-05-10
Reason for Recall
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%.
Firm Action
BD began notifying distributors on April 11, 2018. Customer communications were mailed on April 12-13th, 2018.
US customers will be sent a letter via UPS beginning April 12, 2018.
Distributors were e-mailed on April 11, 2018 and requested that they provide a list of their consignees to facilitate mailing to end users
BD Regions will be contacted via email regarding distribution outside of the US
Distributors were instructed to return customer lists to BD.
Letters will be mailed with UPS tracking, which provides for a 100% effectiveness check. Customer response form will be tabulated.
100% of non-responders will be contacted by phone.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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