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U.S. Department of Health and Human Services

Class 3 Device Recall GranuFlo Dry Acid Concentrate

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  Class 3 Device Recall GranuFlo Dry Acid Concentrate see related information
Date Initiated by Firm November 26, 2012
Date Posted January 17, 2013
Recall Status1 Open3, Classified
Recall Number Z-0678-2013
Recall Event ID 63768
510(K)Number K030497  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL
Catalog Number: OFD3251-3B

Product Usage:
GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
Code Information Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006,
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall
GranuFlo Dry Acid Concentrate may show discoloration
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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
Quantity in Commerce 14,240 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE
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