Device product
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.
Z-1827-2012
Product summary
- Event
- Event 62108
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1827-2012
Official wording
Reason: Risk of Alkalosis with acetate containing dialysis acid concentrates
Code information: All lots
Distribution pattern: Nationwide Distribution and the country of Guam.
Derived failure modes
-
Unknown
Risk of Alkalosis with acetate containing dialysis acid concentrates