Fresenius Medical Care Holdings, Inc. NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Brand
Fresenius Medical Care Holdings, Inc.
Lot Codes / Batch Numbers
UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Products Sold
UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 due to The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On June 1, 2022, the firm reached out to its affected customers via telephone to explain the product issue. Customers were instructed to identify and segregate the affected product immediately and remove the product from inventory. If customers had any product to return, the recalling firm would have a customer service representative follow up with the customer. Customers were reminded to always inspect packaging for leaks.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026