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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 Recall
NaturaLyte Liquid Bicarbonate Concentrate
see related information
Date Posted June 09, 2014
Recall Status1 Open
Recall Number Z-1739-2014
Recall Event ID 68135
Premarket Notification
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, Massachusetts 02451-1521
Manufacturer Reason
for Recall
Container cap may contain foreign material- 0.60% - 0.80% Manganese
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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