NaturaLyte recallZ-1010-2018 · Fresenius Medical Care Renal Therapies Group, LLC · initiated Sep 29, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Renal Therapies Group, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
FDA root cause category: Release of Material/Component prior to receiving test results
What the company is doing
The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 10/4/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees are instructed to: " Immediately examine your stock to determine whether you have any Naturalyte Liquid Acid Concentrate from the lot listed. " If any product of this lot is found, discontinue use immediately. " Place all units in a secure, segregated area. " Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. " Promptly fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or SCAN and email to: [email protected].' and "Route the letter to others in your organization that may have any of the affected product that is subject to this recall. Please note that the Naturalyte Liquid Acid Concentrate matching the Lot Number listed in the notification is the only lot subject to this recall. If you have any additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.
Recall details
- Recall number
- Z-1010-2018
- Status
- Terminated
- Initiated by the company
- Sep 29, 2017
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 598 cases
- Product code
- KPO
- FDA submissions
- K070177
- Distribution
- US Distribution to states of: CA, FL, KS, LA, and TX.
Product description
NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Code information (models, lots, serial numbers)
Lot # 17KTAC076; UDI-00840861101696
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NaturaLyte 08-2251-0Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)3 recalls1 death20 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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