FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Renal Therapies Group, LLC: 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.
- Recall number
- Z-1010-2018
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-09-29
- Posted
- not on file
- Terminated
- 2018-08-09
- Reason
- 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.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- 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: NOTIFYRA@fmc-na.com.' 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.
- Quantity
- 598 cases
- Distribution
- US Distribution to states of: CA, FL, KS, LA, and TX.
- Lot, serial or model codes
- Lot # 17KTAC076; UDI-00840861101696
- 510(k) numbers
- ["K070177"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28