FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
- Recall number
- Z-2373-2015
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
- Status
- Open, Classified
- Initiated
- 2015-07-16
- Posted
- 2015-08-12
- Terminated
- not on file
- Reason
- Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
- Root cause
- Process control
- Action
- Fresenius Medical NA issued an Urgent Expanded Medical Device Recall letter on 7/16/15 to clinics and patients. The letter identified the affected product, explained the reason for the expansion, and instructed users to immediately examine their stock to determine whether there was any Naturalyte Liquid Bicarbonate Concentrate beginning with 15AMLB, 15BMLB, 15CMLB. Users are to discontinue use immediately if any product of these lots is found, . All units are to be placed in a secure, segregated area. If affected product was on the machine prior to patient treatment, a [Heat Disinfect] program should be performed. The attached Reply Form should be completed and returned. Contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
- Quantity
- 2,264,028
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lots begin with: 15AMLB, 15BMLB, 15CMLB.
- 510(k) numbers
- ["K071387"]
- 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