Z-2629-2014Class II

BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single...

Name: Z-2629-2014 BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2014-06-23
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2014-06-23 / Terminated

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or... on 2014-06-23. FDA classified it as Class II and gives the reason as "Products were held at improper storage temperature". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2629-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Posted: 2014-09-12
Terminated: 2021-01-29
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Products were held at improper storage temperature
FDA root cause: Storage
Action: Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate or BD Collection Tubes. If customers have the affected product, they will be instructed to contact FMC-RTG Customer Service to have the product replaced. On July 10, 2014 Fresenius issued a clarification letter to users to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as the products were exposure to higher temperatures than recommended. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.
Quantity in commerce: 3 boxes
Distribution: Distributed in the states of LA, OK, and TX.
Product codes and lots: Lot::3319877

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2629-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2629-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2630-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2631-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2632-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2633-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12
Z-2634-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-12

Product code JKA

K960250Class IIVacutainer Brand Plus Serum & Sst TubesBecton Dickinson Vacutainer Systems / cleared 1996-03-29

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)