FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
- Recall number
- Z-0942-2021
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
- Status
- Terminated
- Initiated
- 2020-12-17
- Posted
- not on file
- Terminated
- 2023-01-05
- Reason
- Bottles Missing Product Label
- Root cause
- Packaging change control
- Action
- Fresenius Medical Care (FMCRTG isssued URGENT MEDICAL DEVICE RECALL on 12/17/20 ia First Class Mail, letter states reason for recall, health risk and action to take: RETURN ONLY BOTTLES WITH NO LABEL OPEN AND CHECK ALL BOTTLES IN CASES of Lot Number 20NTAC040. " If you find any bottles from this lot with no labels, place the product in a secure, segregated area. Please contact FMCRTG Customer Service at 1-800-323-5188 for instructions on how to return the product and receive credit. o If returning single bottles, please place affected product in a box for pick up. Please contact FMCRTG Customer Service at 1-800-323-5188 if you have unique circumstances or an urgent need concerning product delivery.
- Quantity
- 2,280 cases (9,120 bottles)
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot code: 20NTAC040
- 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
- 2026-10-14
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