Z-0571-2016Class II

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray...

Name: Z-0571-2016 BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray...
Creator: Becton Dickinson & Company
Published: 2015-12-03
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-12-03 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD... on 2015-12-03. FDA classified it as Class II and gives the reason as "Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment". 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-0571-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-03
Posted: 2015-12-31
Terminated: 2018-10-19
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA 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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: The firm, BD, issued an "URGENT PRODUCT RECALL" notifications/Recall Response Forms to their customers dated 12/3/2015 via email and/or UPS 2nd Day Mail. The notification identified the reason for the recall; how to identify affected product; and actions to be taken. The customers were instructed customers to immediately review their inventory; complete the enclosed Recall Response Form and fax (1-866-873-0312 it to BD or email it to [email protected]; and return all affected products with the completed Recall Response Form following instructions on the enclosed packing instruction, even if you do not have any affected lot in your inventory. If customers have any questions or require assistance with the return of the recalled product and/or availability of replacement product, they were instructed to contact 1-888-628-0732 between 8AM and 5 PM ET Monday through Friday.
Quantity in commerce: 29,815,600 units in total
Distribution: Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
Product codes and lots: Catalog Reference #367844; Lot number 5154624 Catalog Reference #367862; Lot numbers 5089771 and 5187753 Catalog Reference #368021; Lot number 5089820

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0571-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0567-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-31
Z-0568-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-31
Z-0569-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-31
Z-0570-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-31
Z-0571-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-31

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)