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.
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.
The product may have been stored below recommended temperatures, causing leaks in the packaging. Leaks could lead to biological contamination, increasing the risk of bloodstream infections if the solution comes into contact with the body.
Patients using this dialysis solution are most at risk. The recall affects specific lot numbers and model numbers sold by Fresenius Medical Care.
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.
Look for the model number 08-2301-3 and lot number 21AGAC009 on the product label.
The product may have been exposed to cold storage temperatures, which could cause leaks. If you have the affected model and lot number, you should check with Fresenius Medical Care for guidance.
The recall record does not specify a remedy, so contact Fresenius Medical Care directly for instructions on next steps.
Check for the model number 08-2301-3 and lot number 21AGAC009 on the product label.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1311-2022 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1311-2022 from Fresenius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
