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U.S. Department of Health and Human Services

Class 2 Device Recall Naturalyte Liquid Acid

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  Class 2 Device Recall Naturalyte Liquid Acid see related information
Date Initiated by Firm November 23, 2020
Date Posted January 11, 2021
Recall Status1 Open3, Classified
Recall Number Z-0833-2021
Recall Event ID 86939
510(K)Number K070177  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Code Information Lot Numbers: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010  Additional Affected lots as of 3/17/21: 20LXAC053 20LXAC047 20LXAC054 20LXAC049 20NXAC016 20LXAC094 20NXAC024 20NXAC025 20LXAC091 20LXAC101 20LXAC077 20LXAC048 20NXAC010 20LXAC076 
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information Contact Fresenius Medical Care Technical Service
800-227-2572
Manufacturer Reason
for Recall		 The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Recall notification letter dated 11/23/20 was sent to customers. Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) previously issued Urgent Medical Device Alerts on November 7, 2020 and November 14, 2020 alerting you to issues pertaining to the sodium level in the Naturalyte¿ Liquid Acid concentrate and Citrasate¿ Liquid Acid concentrate products impacting 105 lots, manufactured at the Oregon, Ohio facility between September 9, 2020 and October 29, 2020. After further testing, FMCRTG is now voluntarily recalling 28 of the 105 lots for one or both of the following reasons: " The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. " Calcium concentration is below manufacturing specification. The 28 lots were released for distribution between September 30, 2020 and November 20, 2020. Please check your stock and discontinue use and/or distribution of the products. If you have any listed lot numbers, place the product in a secure, segregated area. Please contact Stericycle at 1-866-912-9552 for instructions on how to return the product and receive credit This is EVENT# 5857. o If returning single bottles, please place affected product in a box for pick up. o In order to receive credit for your impacted product, you must call the Stericycle phone number above and provide quantities for return. Additional Information: If urgent replacement of product is needed, please call FMCRTG Customer Service at 1-800-323-5188. Otherwise, please add any additional product request to your next scheduled delivery. We apologize for any inconvenience. Please complete and return the enclosed Reply Form at your earliest convenience and contact our Customer Services team at 1-800-323-5188 with any additional questions. Please contact our Medical Information team at 1-855-616-2309 to discuss any medical or scie
Quantity in Commerce 3083 cases
Distribution US 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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