Recall Z-1827-2012— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1827-2012
Creator: U.S. Food and Drug Administration
Published: 2012-03-29

Class I · Terminated

Class I FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2012-03-29, terminated 2017-07-20. It names one FDA 510(k) clearance: K030497. 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.. Reason: Risk of Alkalosis with acetate containing dialysis acid concentrates.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class I
Status: Terminated
Initiated: 2012-03-29
Terminated: 2017-07-20
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K030497 — FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIESFresenius Medical Care·cleared 2003-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Risk of Alkalosis with acetate containing dialysis acid concentrates

Data sourced from openFDA. This site is unofficial and independent of the FDA.