Recall Z-2087-2021— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2087-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-28

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2021-04-28, terminated 2022-08-08. It names one FDA 510(k) clearance: K191474. Product: NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.. Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-28
Terminated: 2022-08-08
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K191474 — NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)Fresenius Medical Care Renal Therapies Group, LLC·cleared 2020-02-24

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 Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

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