Z-0295-2016Class II

Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate...

Name: Z-0295-2016 Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate...
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2015-10-23
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2015-10-23 / Terminated / root cause: design

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis on 2015-10-23. FDA classified it as Class II and gives the reason as "Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0295-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-23
Posted: 2015-11-18
Terminated: 2021-03-02
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Root cause tag: design
FDA root cause: Device Design
Action: Fresenius issued an Urgent - Medical Device Correction notification, dated October 21, 2015, on 10/27/15. The letter identified the affected device and the reason for the recall. It also contained instructions (on how to perform the required wiring modification) along with a Reply Form. Customers are to return the form after completing the modification. Inquiries regarding the correction should be directed to Fresenius Technical Services at 800-227-2572, referencing the Field Action number FA-2015-01-W.
Quantity in commerce: 348 units
Distribution: Nationwide Distribution.
Product codes and lots: All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0295-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0294-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0295-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18
Z-0296-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18

Product code KPO

K131611Class IIFresenius Dry Acid Dissolution UnitsFresenius Medical Care North America / cleared 2013-08-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)