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 (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal failure during hemodialysis procedure.

FDA Recall Z-1827-2012 · Posted 2012-06-25

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2012-03-29
Date Terminated2017-07-20

Reason for Recall

Risk of Alkalosis with acetate containing dialysis acid concentrates

Firm Action

Fresenius Medical Care sent an "IMPORTANT PRESCRIBING INFORMATION" letter dated March 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Reply Form was enclosed for customers to complete and return via fax to 781-699-9635. Contact Customer Service at 1-800-323-5188 or Medical Information at 1-855-616-2309 for questions regarding this recall.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution and the country of Guam.

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.

↑