Z-0517-2019Class III

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

Name: Z-0517-2019 Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2018-10-09
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2018-10-09 / Terminated

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis on 2018-10-09. FDA classified it as Class III and gives the reason as "Discolored powder has confirmed the presence of a foreign substance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0517-2019
Classification: Class III
Status: Terminated
Initiated: 2018-10-09
Posted: 2018-11-29
Terminated: 2021-08-05
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Discolored powder has confirmed the presence of a foreign substance
FDA root cause: Under Investigation by firm
Action: Fresenius issued on 10/9/18 via Certified Mail An Urgent Medical Device Recall Customer Notification to affected consignees asking the consignees to check their stock immediately. If they have any listed GranuFlo Dry Acid Concentrate lot. numbers discontinue use immediately and place the product in a secure, segregated area. The Urgent Medical Device Recall Customer Notification ask for the return of the affected lots and to contact Stericycle on instructions how to return the recalled lots. Contact Stericycle at 1-888-671-8851 for instructions on how to return the recalled product. This is EVENT# 10021.
Quantity in commerce: 92225
Distribution: Distribution US nationwide and Mexico
Product codes and lots: Lot code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0517-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0516-2019	Class III	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-29
Z-0517-2019	Class III	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-29
Z-0518-2019	Class III	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-29

Product code KPO

K030497Class IIFresenius Naturalyte Granuflo Dry Acid Concentrate 10Xx Series, 24Xx Series, 30Xx SeriesFresenius Medical Care / cleared 2003-05-20

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)