Recall Z-2634-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2634-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-23

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-06-23, terminated 2021-01-29. It names one FDA 510(k) clearance: K954592. 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.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-23
Terminated: 2021-01-29
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K954592 — VACUTAINER BRAND PST PLASMA SEPARATION TUBEBecton Dickinson Vacutainer Systems·cleared 1995-11-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.