CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report

BD Vacutainer Sst Tubes (Red/Grey Top Sst Tube recalled

Fresenius Medical Care Holdings is recalling BD Vacutainer SST Tubes (RED/GREY TOP SST, distributed in Louisiana, Oklahoma, Texas. The recall was initiated on 23 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot(s): 3305588 and 4006903

Quantity recalled9 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2631-2014
FDA event ID: 68585
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jun 2014
FDA classified: 12 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Temperature Abuse
Device type: Test Kits & Diagnostics

Timeline

23 Jun 2014	Recall initiated by company
12 Sep 2014	Classified by FDA	+81 days
24 Sep 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products were held at improper storage temperature

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.

Where it was distributed

Distributed in the states of LA, OK, and TX.

Louisiana Oklahoma Texas

Questions about this recall

Why was it recalled?

Products were held at improper storage temperature

Which lots are affected?

Lot(s): 3305588 and 4006903

Where was it sold?

Distributed in the states of LA, OK, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 68585

This product is part of a recall event; the main page for the event is BD Vacutainer Pst Tubes (Gold Top Pst Tube recalled.

Reported	Class	Recall	Company	Reason	Where
24 Sep 2014	CLASS II	BD Vacutainer Pst Tubes (Gold Top Pst Tube recalled	Fresenius Medical Care Holdings	Temperature Abuse	LA, OK, TX
24 Sep 2014	CLASS II	BD Vacutainer Citrate Tubes (Light Blue Top Tube recalled	Fresenius Medical Care Holdings	Temperature Abuse	LA, OK, TX
24 Sep 2014	CLASS II	BD Vacutainer Edta Tubes (Lavender Top Tube recalled	Fresenius Medical Care Holdings	Temperature Abuse	LA, OK, TX
24 Sep 2014	CLASS II	BD Vacutainer Trace Element Tubes (Royal Blue Top Tube recalled	Fresenius Medical Care Holdings	Temperature Abuse	LA, OK, TX
24 Sep 2014	CLASS II	BD Vacutainer Serum Tubes (Red Top Plain Tube recalled	Fresenius Medical Care Holdings	Temperature Abuse	LA, OK, TX

More recalls from Fresenius Medical Care Holdings

All 165

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide