Recall Z-1827-2012 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Fresenius Medical Care Holdings, Inc.
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.
| Date | Jun 25, 2012 (initiated Mar 29, 2012) |
| Status | Terminated |
| Reason | Risk of Alkalosis with acetate containing dialysis acid concentrates |
| Root cause | Labeling False and Misleading |
| 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. |
| Distribution | Nationwide Distribution and the country of Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030497 | FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES Fresenius Medical Care, May 20, 2003 |