Date Initiated by Firm | November 26, 2012 |
Date Posted | January 17, 2013 |
Recall Status1 |
Terminated 3 on June 21, 2016 |
Recall Number | Z-0677-2013 |
Recall Event ID |
63768 |
510(K)Number | K030497 |
Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
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Product | Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL
Catalog Number: OFD2201-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. |
Code Information |
Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014 |
Recalling Firm/ Manufacturer |
Fresenius Medical Care Holdings, Inc. 920 Winter St Waltham MA 02451-1521
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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 | 17,782 units |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPO
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