FDA recall Z-0823-2021

Product

NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - 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-0823-2021