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U.S. Department of Health and Human Services

Class 2 Device Recall Naturalyte Liquid Bicarbonate Concentrate

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  Class 2 Device Recall Naturalyte Liquid Bicarbonate Concentrate see related information
Date Initiated by Firm July 16, 2015
Date Posted August 12, 2015
Recall Status1 Open3, Classified
Recall Number Z-2373-2015
Recall Event ID 71724
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
A Dialysate Concentrate for Hemodialysis (liquid)
Product Code: 08-4000-LB
Code Information Lots begin with: 15AMLB, 15BMLB, 15CMLB.
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
800-662-1237
Manufacturer Reason
for Recall		 Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
FDA Determined
Cause 2		 Process control
Action Fresenius Medical NA issued an Urgent Expanded Medical Device Recall letter on 7/16/15 to clinics and patients. The letter identified the affected product, explained the reason for the expansion, and instructed users to immediately examine their stock to determine whether there was any Naturalyte Liquid Bicarbonate Concentrate beginning with 15AMLB, 15BMLB, 15CMLB. Users are to discontinue use immediately if any product of these lots is found, . All units are to be placed in a secure, segregated area. If affected product was on the machine prior to patient treatment, a [Heat Disinfect] program should be performed. The attached Reply Form should be completed and returned. Contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
Quantity in Commerce 2,264,028
Distribution Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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