Z-0456-2016Class II

BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes

Name: Z-0456-2016 BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes
Creator: Becton Dickinson & Company
Published: 2015-11-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-11-17 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed... on 2015-11-17. FDA classified it as Class II and gives the reason as "Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood...". 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-0456-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Posted: 2015-12-21
Terminated: 2016-06-08
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: BD sent an "Urgent Product Recall notifications/Recall Response Forms dated November 17, 2015 via email and/or UPS Next Day Mail on November 17, 2015 to their customers. The notification identifies the affected product and problem and actions to be taken. Customers are requested to take the following actions (1) Immediately review their inventory and quarantine the product subject to the recall and immediately discontinue the shipment of the affected product (2) complete the enclosed Recall Response Firm and fax it bat to BD at 1.866.873.0312 or emai to [email protected] (3) Return all affected products with the completed Recall Response Form following the instruction on the enclosed packing instruction and (5) if distributed, identify your customers and notify them immediately of this product recall. If the customers had any questions, they were instructed to contact BD at 1.888.628.0732 between 8 AM and 5 PM Monday through Friday.
Quantity in commerce: 4,835,000 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.
Product codes and lots: Catalog (Ref) # 367856; Lot Number 5014806

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0456-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0456-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-21

Product code JKA

K981013Class IIVacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum TubeBecton Dickinson Vacutainer Systems / cleared 1998-06-17

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)