Recall Z-1739-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1739-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-01

Class III · Terminated

Class III FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-05-01, terminated 2016-06-15. It names one FDA 510(k) clearance: K071387. Product: NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; 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: Container cap may contain foreign material- 0.60% - 0.80% Manganese.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class III
Status: Terminated
Initiated: 2014-05-01
Terminated: 2016-06-15
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 to be used with a hemodialysis unit; 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

Container cap may contain foreign material- 0.60% - 0.80% Manganese

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