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U.S. Department of Health and Human Services

Class 2 Device Recall Naturalyte Acid Concentrate

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 Class 2 Device Recall Naturalyte Acid Concentratesee related information
Date Initiated by FirmMarch 16, 2012
Date PostedMay 15, 2012
Recall Status1 Terminated 3 on January 28, 2014
Recall NumberZ-1612-2012
Recall Event ID 61418
510(K)NumberK981043 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductFresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Code Information Lot 11PTAC022. Expiration Date: 11/30/2013
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information ContactSAME
800-662-1237
Manufacturer Reason
for Recall		Sodium content does not meet product requirements
FDA Determined
Cause 2		Process control
ActionFresenius Medical Care North America sent an "URGENT PRODUCT RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine whether they have any affected product. A fax back form was included for customers to complete and return. Contact FMCNA Customer Service Team at 1-800-323-5188 for questions regarding this notice.
Quantity in Commerce154 units
DistributionNationwide Distribution.
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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