Recall Z-1639-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1639-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-10

Class I · Ongoing

Class I FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-04-10. It names one FDA 510(k) clearance: K071387. Product: Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. Reason: Naturalyte Liquid Bicarbonate maybe contaminated.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2014-04-10
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K071387 — FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LBFresenius Medical Care North America·cleared 2007-06-15

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

Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

Reason for recall

Naturalyte Liquid Bicarbonate maybe contaminated

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