Lower riskMedical device recall · FDA · Published June 1, 2022
Fresenius NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal Recall: Risk of Leaks and Infection
Fresenius Medical Care recalls NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal due to potential leaks from improper storage, which could cause biological contamination and bloodstream infections. Learn if you have the affected product.
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.
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Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 950 · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
Fresenius Medical Care is recalling NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal products that may have been exposed to cold storage temperatures. This could cause leaks in the packaging, increasing the risk of biological contamination and potential bloodstream infections. Read more at govinfonow.com/recall/60569-fresenius-naturalyte-2301-2k-3-0-ca-1-mg-gal.
“Fresenius NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal Recall: Risk of Leaks and Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60569-fresenius-naturalyte-2301-2k-3-0-ca-1-mg-gal. Based on FDA recall #Z-1311-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1311-2022%22&limit=1).
The FDA announced on June 1, 2022, that Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal dialysate concentrate due to potential packaging leaks from below-recommended storage temperatures. These leaks may lead to biological contamination and an increased risk of bloodstream infection.
How to tell if you have it
Brand: Fresenius Medical Care
Product: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
UPC: 00840861101702
Lot code: 21AGAC009
Distribution: US Nationwide, including Texas and Louisiana
The hazard
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.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has had 44 other recalls on record since April 14, 2014. Recent recalls include a May 12, 2026 notice regarding Bicarby Dialysate leaks and a May 11, 2026 recall of the 5008X Blood Tubing Set for online port errors. Other recent recalls of similar products include Fresenius Medical Care 5008X Blood Tubing Set Recall (August 10, 2026), Fresenius NaturaLyte Liquid Acid Concentrate Recall (July 14, 2026), and Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (August 10, 2026).
How to tell if you have this one
Check for the model number 08-2301-3 on the product label. The affected lot number is 21AGAC009. This product was sold with a unique device identifier (UDI) starting with (01)00840861101702.
Brand
Fresenius Medical Care
Product
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number 08-2301-3 and lot number 21AGAC009 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Texas and Louisiana.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Louisiana, Texas.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1311-2022 (June 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1311-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.