Z-0968-2018Class II

BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used...

Name: Z-0968-2018 BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used...
Creator: Becton Dickinson & Company
Published: 2017-08-29
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-08-29 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations... on 2017-08-29. FDA classified it as Class II and gives the reason as "A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of...". 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-0968-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-29
Posted: 2018-03-12
Terminated: 2019-05-16
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: In August of 2017 All US direct consignees were contacted via e-mail and/or UPS mail. An Urgent Product Removal Recall letter was issued, identifying the affected device and the reason for the recall. It also requested customers to review their inventory and quarantine any affected devices, which will be returned to the firm for replacement. The Customer Recall Response Form should be completed and returned regardless of whether there is any affected devices on hand. For questions or concerns please contact Customer Service at 1-855-215-4992.
Quantity in commerce: 8,494,000
Distribution: Nationwide Distribution
Product codes and lots: Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0968-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0968-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-12

Product code JKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)