FDA-Device2014-09-24Class II
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.
Fresenius Medical Care Holdings, Inc.
Hazard
Products were held at improper storage temperature
Sold states
Distributed in the states of LA, OK, and TX.
Affected count
13 Each
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2634-2014Don't want to check this manually?
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