Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
This recall has been terminated (originally issued January 17, 2013).
- Recall Initiated
- November 26, 2012
- Posted
- January 17, 2013
- Terminated
- June 21, 2016
- Recall Number
- Z-0684-2013
- Quantity
- 2711 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
GranuFlo Dry Acid Concentrate may show discoloration
Distribution
US Nationwide Distribution
Lot / Code Info
Lot Number:12PXGF002
Root Cause
Nonconforming Material/Component
Action Taken
Fresenius Medical Care North America notified consignees by telephone on November 26, 2012 and follow-up letter on November 30, 2012 of the product recall. On January 10, 2013, the firm expanded there recall to an additional 32 lots (34 lots total). Customers were instructed to examine their inventory immediately, discontinue use, place all units in quarantine and return to Fresenius Medical Care North America. Customers were advised to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. For questions contact the GranuFio Recall Line at 1-888-803-0509