FDA recall Z-0822-2021

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

Product

NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Reason for recall

The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2020-11-07
Report date: 2021-01-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0822-2021