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U.S. Department of Health and Human Services

Class 1 Device Recall Fresenius GranuFlo (powder) Acid Concentrate

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 Class 1 Device Recall Fresenius GranuFlo (powder) Acid Concentratesee related information
Date Initiated by FirmMarch 29, 2012
Date PostedJune 25, 2012
Recall Status1 Terminated 3 on July 20, 2017
Recall NumberZ-1827-2012
Recall Event ID 62108
510(K)NumberK030497 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductFresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal failure during hemodialysis procedure.
Code Information All lots
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		Risk of Alkalosis with acetate containing dialysis acid concentrates
FDA Determined
Cause 2		Labeling False and Misleading
ActionFresenius Medical Care sent an "IMPORTANT PRESCRIBING INFORMATION" letter dated March 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Reply Form was enclosed for customers to complete and return via fax to 781-699-9635. Contact Customer Service at 1-800-323-5188 or Medical Information at 1-855-616-2309 for questions regarding this recall.
DistributionNationwide Distribution and the country of Guam.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPO
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