FDAClass IIJuly 13, 2022

NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal recall: Contamination

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

Why was NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
3 cases
Distribution
US Nationwide distribution in the states of Texas and Louisiana.
Recall date
July 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls