PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 24, 2014 Initiated: June 23, 2014 #Z-2634-2014

Product Description

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 for Recall

Products were held at improper storage temperature

Details

Units Affected
13 Each
Distribution
Distributed in the states of LA, OK, and TX.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 13 Each.
Why was this product recalled?
Products were held at improper storage temperature
Which agency issued this recall?
This recall was issued by the FDA Devices on September 24, 2014. Severity: Moderate. Recall number: Z-2634-2014.