Z-0084-2018Class II

BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for...

Name: Z-0084-2018 BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for...
Creator: Becton Dickinson & Company
Published: 2017-01-27
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-01-27 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No... on 2017-01-27. FDA classified it as Class II and gives the reason as "After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0084-2018
Classification: Class II
Status: Terminated
Initiated: 2017-01-27
Posted: 2017-11-09
Terminated: 2019-02-06
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Sodium Polyanetholesulfonate 5.95 mg Sodium Chloride 14.4 mg Blood Collection Tubes for Microbiological Studies (8.3 mL * 16x100mm) Catalog No. 364960
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: After a receiving a customer complaint for incorrect labeling, BD has confirmed that a portion of SPS tubes associated with catalog 364960, lot 6090812 were incorrectly labeled at the case and shelf pack level.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: BD notified their customers on 1/27/2017 via email and/or UPS 2nd Day Mail. Stericycle is handling returns.
Quantity in commerce: 90,000 tubes
Distribution: Nationwide, Canada
Product codes and lots: Lot no. 6090812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0084-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0084-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-09

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)