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

FDA Device Recall #Z-0518-2019 — Class III — October 9, 2018

Recall Summary

Recall Number Z-0518-2019
Classification Class III — Low risk
Date Initiated October 9, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fresenius Medical Care Renal Therapies Group, LLC
Location Waltham, MA
Product Type Devices
Quantity 22320

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

Distribution Pattern

Distribution US nationwide and Mexico

Lot / Code Information

Lot code: 18BTGF016 18ETGF006 18ETGF014 18HTGF015 18LTGF003

Other Recalls from Fresenius Medical Care Renal Therapie...

Recall # Classification Product Date
Z-2151-2019 Class II Liberty Cycler Cassettes (a disposable cassette... May 29, 2019
Z-1699-2019 Class III 2008T BlueStar Machine Software v.2.72-Hemodial... Apr 3, 2019
Z-0658-2019 Class II Optiflux F160NR Capillary High Flux Dialyzer Si... Nov 5, 2018
Z-0516-2019 Class III Fresenius Granuflo Dry Acid Concentrate- 2K 2.0... Oct 9, 2018
Z-0517-2019 Class III Fresenius Granuflo Dry Acid Concentrate- 2K 2.5... Oct 9, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.