NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Check against the official notice below — it lists the full affected range.
Fresenius Medical Care is recalling NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal dialysate solution due to potential exposure to below-recommended storage temperatures. The temperature exposure may have caused leaks in the packaging, which could allow biological contamination to occur. If contaminated product is used, patients face an increased risk of bloodstream infection. The recall affects 3 cases that were distributed nationwide in Texas and Louisiana, identified by Lot 21AGAC009 and UDI (01)00840861101702 (17) 230131 (10) 21AGAC009.
The recall record does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 3 cases Lot/code info: UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.