Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1311-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 1, 2022

Date Posted: July 13, 2022

Recall Number: Z-1311-2022

Event ID: 90419

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.

Status: Terminated

Product Quantity: 3 cases

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of Texas and Louisiana.

Voluntary or Mandated:

Voluntary: Firm initiated