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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Medical Naturalyte Liquid Bicarbonate Concentrate

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  Class 2 Device Recall Fresenius Medical Naturalyte Liquid Bicarbonate Concentrate see related information
Date Initiated by Firm June 23, 2014
Date Posted September 23, 2014
Recall Status1 Open3, Classified
Recall Number Z-2686-2014
Recall Event ID 69158
510(K)Number K071387  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Fresenius Naturalyte Liquid Bicarbonate Concentrate
Product 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: 14BMLB012
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
Product was held at temperature above the labeled recommended storage temperature
FDA Determined
Cause 2
Storage
Action Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and faxback form Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate. If customers have the affected product, they are instructed to contact FMC-RTG Customer Service to have the product replaced. A revised/clarification letter dated 7/10/14 issued to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as products were exposed to temperatures higher than their recommended storage temperature during transportation on May 5, 2014. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.
Quantity in Commerce 72 cases
Distribution Distributed in Texas.
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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