RecallRadar

FDA Device recall Z-2634-2014

BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate…

On 2014-09-24 the FDA classified a Class II recall of BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate… by Fresenius Medical Care Holdings, citing products were held at improper storage temperature.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2634-2014
ClassificationClass II
Statusterminated
Initiated2014-06-23
Published2014-09-24
Last updated2026-09-13 11:53 UTC
CompanyFresenius Medical Care Holdings
DistributionLA, OK, TX

Product

BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Reason

Products were held at improper storage temperature

Identifiers

code_infoLot: B011403

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2634-2014%22

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