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U.S. Department of Health and Human Services

Class 3 Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate

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  Class 3 Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate see related information
Date Initiated by Firm March 23, 2011
Date Posted June 10, 2011
Recall Status1 Terminated 3 on September 12, 2012
Recall Number Z-2551-2011
Recall Event ID 58736
510(K)Number K071387  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid
Part number: 08-4000-LB

Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Code Information Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)
Recalling Firm/
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact Denise Oppermann
Manufacturer Reason
for Recall
Mislabeled: incorrect lot number printed on case labels
FDA Determined
Cause 2
Employee error
Action Fresenius sent an CUSTOMER NOTIFICATION LETTER letter dated April 18, 2011, to all affected customers via Certified Mail, Return Receipt Requested. Fresenius also contacted affected customers by telephone April 18, 2011, The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to examine their stock to determine whether they have the incorrect case label and are asked to remove the correctly labeled product from the incorrectly labeled case and discard the case. Acknowledgement forms were Fax-back forms for clinics and mail-back forms (including self-addressed, stamped envelopes), for home patients. Question or concerns should be directed to Fresenius Customer Service Team at 1- 800.323.5188.
Quantity in Commerce 3,190 cases
Distribution Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
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