Z-2084-2021Class II

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one...

Name: Z-2084-2021 Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2021-04-28
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2021-04-28 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream... on 2021-04-28. FDA classified it as Class II and gives the reason as "Exposed to freezing temperatures due to refrigerated truck malfunctions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2084-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-28
Posted: 2021-07-16
Terminated: 2022-08-08
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are 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.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Exposed to freezing temperatures due to refrigerated truck malfunctions
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Fresenius issued telephone script communication on April 28.2021 stating reason for recall, heath risk and action to take: Tell them you already contacted their Home Therapy Nurse to alert them that you would be calling them. o The purpose of my call today is that you received a delivery from us on (either Feb 22nd or Feb 23rd). o The truck you received a delivery from had a temperature malfunction due to the bad storms Texas experienced back in February. This caused the product you were delivered to be exposed to freezing or near freezing temperatures for about 3 hours. o o I see you received on . o (if received any PD SOLUTION/SALINE/or CONCENTRATES): Explain that the solutions inside their product are not affected and that we have freeze/thaw studies that prove this. Explain that due to the freezing temperatures, the packaging may become compromised, and they may have seen leaks. For the other products such as Hand Sanitizer and other ancillary products, again, the product could be compromised according to their packaging requirements listed on their packaging. o We are giving you the opportunity to return these products if you choose to do so at this time. o If returning product(s): o Fill out RGA spreadsheet with customer information including how much product they are returning (include lot# and amount returning). Driver will pick up returned products on their next scheduled visit. Fresenius Corrections and Removals Rep: Email Post Market Surveillance to open a complaint against product. o If not returning product(s): o Thank them for their time and reiterate to always inspect their packaging for leaks as this is what they are trained to do anyways from their Home Therapies Nurse. If you have any questions call 781-699-2243 or email: [email protected]
Quantity in commerce: (1) 40 cases (2) 3 cases (3) 4 cases
Distribution: US Distribution to: TX only
Product codes and lots: Lot Number/UDI: (1) 21ATGF013 (01)00884086110135 0FD3251-3B (2) 20SXGF010 (01)00840861101597 0FD3251-3B (3) 20SXGF013 (01)00840861101597

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2084-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2082-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2083-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2084-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2085-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2086-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2087-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2088-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2089-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16
Z-2090-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16

Product code KPO

K192209Class IICitrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC / cleared 2020-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)