FDA recall Z-0820-2025

Nipro Renal Soultions USA, Corporation · Class II · device

Product

Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

Reason for recall

The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

Distribution

US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.

Key facts

Status
Ongoing
Initiation date
2024-11-22
Report date
2025-01-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lewisberry, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0820-2025