Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0517-2019 · Posted None

Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeKPO
Date Initiated2018-10-09
Date Terminated2021-08-05
Product Quantity92225

Reason for Recall

Discolored powder has confirmed the presence of a foreign substance

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution US nationwide and Mexico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030497FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIESFresenius Medical Care · 2003-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑