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U.S. Department of Health and Human Services

Class 3 Device Recall NaturaLyte Liquid Bicarbonate Concentrate

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  Class 3 Device Recall NaturaLyte Liquid Bicarbonate Concentrate see related information
Date Initiated by Firm May 01, 2014
Date Posted June 09, 2014
Recall Status1 Terminated 3 on June 15, 2016
Recall Number Z-1739-2014
Recall Event ID 68135
510(K)Number K071387  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB.

The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Code Information Lot Number: 14CMLB006
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		 Container cap may contain foreign material- 0.60% - 0.80% Manganese
FDA Determined
Cause 2		 Equipment maintenance
Action Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product.
Quantity in Commerce 12 bottles
Distribution Distributed in the state of MO.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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