Recall Z-0679-2013— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0679-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-26

Class III · Terminated

Class III FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2012-11-26, terminated 2016-06-21. It names one FDA 510(k) clearance: K030497. Product: Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.. Reason: GranuFlo Dry Acid Concentrate may show discoloration.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-11-26
Terminated: 2016-06-21
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 Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

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