Z-1180-2018Class II

BD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog...

Name: Z-1180-2018 BD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog...
Creator: Becton Dickinson & Company
Published: 2017-09-18
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-09-18 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to... on 2017-09-18. FDA classified it as Class II and gives the reason as "Increased amount of residual blood present on the top of stopper well after venipuncture". 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-1180-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-18
Posted: 2018-03-26
Terminated: 2019-02-04
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring and zinc testing in plasma for in vitro diagnostic use.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Increased amount of residual blood present on the top of stopper well after venipuncture
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On September 22, 2017, BD distributed URGENT PRODUCT REMOVAL RECALL notices to distributors via email. Distributors and customers were mailed via USPS. Customers are advised to take to take the following actions: 1. Discontinue use of the tubes. 2. Complete and return the Customer Recall Response Form via fax to 1-855-544-4851 or via email to [email protected]. 3. Return all affected products using the enclosed packaging instructions and include the completed Recall Response Form with the product. Upon receipt of the returned product, BD will issue alternate product. Customers with questions may call 1-855-215-5168, Monday through Friday between 8AM and 5 PM, EST. For further questions, please call (201) 847-6800.
Quantity in commerce: 1,976,000 tubes
Distribution: USA (nationwide)
Product codes and lots: All Lot Numbers Expiration Dates: November 30, 2017 - July 31, 2018 UDI No.: 50382903650434 50382903650441 50382903650458 50382903650472

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1180-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1180-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code JKA

K160657Class IIBD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company / cleared 2016-09-23

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)