Z-1189-2017Class II

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number...

Name: Z-1189-2017 BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number...
Creator: Becton Dickinson & Company
Published: 2017-01-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-01-16 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety... on 2017-01-16. FDA classified it as Class II and gives the reason as "A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant". 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-1189-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-16
Posted: 2017-02-10
Terminated: 2018-02-07
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD sent an Urgent Product Recall letter dated January 16, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Recall Response Form and fax the completed form back to BD at 1-844-388-5534 or email the completed form to [email protected]. For questions call 1-844-265-7408.
Quantity in commerce: 1,488,800 tubes
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
Product codes and lots: Lot 6090572

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1189-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1189-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-10

Product code JKA

K945952Class IIVacutainer(r) Brand Plus Pst(tm) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1995-01-18

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)