Z-2258-2018Class II

The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that...

Name: Z-2258-2018 The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that...
Creator: Becton Dickinson & Company
Published: 2018-04-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-04-11 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and... on 2018-04-11. FDA classified it as Class II and gives the reason as "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%". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2258-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-11
Posted: 2018-06-20
Terminated: 2019-05-10
Recalling firm: Becton Dickinson & Co
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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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%.
Root cause tag: manufacturing process
FDA 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. 100% of non-responders will be contacted by phone.
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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2258-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2258-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20
Z-2259-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20
Z-2260-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-20

Product code JKA

K013971Class IIBd Vacutainer Safety Coagulation TubeBecton, Dickinson & CO / cleared 2002-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)