FDA Enforcement
Class III
Terminated
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Recall: Z-0682-2013
·
Reported January 23, 2013
Enforcement
- Recall Number
- Z-0682-2013
- Event ID
- 63768
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 23, 2013
- Initiation Date
- November 26, 2012
- Classification Date
- January 16, 2013
- Termination Date
- June 21, 2016
- Address
- 920 Winter St, N/A, Waltham, MA, 02451-1521, United States
Description
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B 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
Code Info
Lot Number:12NXGF012
Distribution
US Nationwide Distribution
Quantity
2493 units