Recall Z-2260-2018 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
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.
| Date | Apr 11, 2018 |
| Status | Terminated |
| 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%. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013971 | BD VACUTAINER SAFETY COAGULATION TUBE Becton, Dickinson & CO, Feb 1, 2002 |