FDA recall Z-0942-2021

Fresenius Medical Care Holdings, Inc. · Class II · device

Product

Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9

Reason for recall

Bottles Missing Product Label

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2020-12-17
Report date
2021-02-10
Termination date
2023-01-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2021