FDA recall Z-1311-2022

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

Product

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

Reason for recall

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

Distribution

US Nationwide distribution in the states of Texas and Louisiana.

Key facts

Status: Terminated
Initiation date: 2022-06-01
Report date: 2022-07-13
Termination date: 2024-10-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2022