—#163870

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.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K013971
Affected lot / code info: All lots

Why it was recalled

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%.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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.

Timeline

Recall initiated: 2018-04-11
Terminated: 2019-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163870. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.