Class 2 Device Recall Naturalyte Liquid Acid

• Date Initiated by Firm: November 23, 2020
• Date Posted: January 11, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0831-2021
• 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 08-1251-1 - 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: 20LXAC063 20NXAC008 Additional Affected lots as of 3/17/21: 20NXAC005 20LXAC098 20NXAC039 20NXAC008 20LXAC063
• 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: 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: 1686 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