Z-1311-2022 Class II Terminated

Recalled by Fresenius Medical Care Holdings, Inc. — Waltham, MA

Recall Details

Product Type
Devices
Report Date
July 13, 2022
Initiation Date
June 1, 2022
Termination Date
October 7, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 cases

Product Description

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 Pattern

US Nationwide distribution in the states of Texas and Louisiana.

Code Information

UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009