PlainRecalls
FDA Devices Low Class III Terminated

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

Reported: December 5, 2018 Initiated: October 9, 2018 #Z-0518-2019

Product Description

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

Reason for Recall

Discolored powder has confirmed the presence of a foreign substance

Details

Units Affected
22320
Distribution
Distribution US nationwide and Mexico
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 22320.
Why was this product recalled?
Discolored powder has confirmed the presence of a foreign substance
Which agency issued this recall?
This recall was issued by the FDA Devices on December 5, 2018. Severity: Low. Recall number: Z-0518-2019.