Fresenius Medical Care is a leading global provider of renal therapies and dialysis solutions. We offer a wide range of products and services for patients with kidney disease, including hemodialysis and peritoneal dialysis solutions.
The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.
Fresenius Medical Care is a leading global provider of renal therapies and dialysis solutions. We offer a wide range of products and services for patients with kidney disease, including hemodialysis and peritoneal dialysis solutions.
The product is designed for medical use and is safe for patients with kidney disease when used as directed. It is not intended for general consumer use.
Patients with kidney disease
Check the product label for the specific product name, manufacturer information, and expiration date. Ensure the product is used according to the instructions provided by the manufacturer.
Verify the product label to ensure it matches the intended use for patients with kidney disease.
Check the expiration date on the product label to ensure it is within the valid period.
Consult with a healthcare provider to confirm the product is appropriate for your specific condition.
Fresenius Medical Care is a leading global provider of renal therapies and dialysis solutions. We offer a wide range of products and services for patients with kidney disease, including hemodialysis and peritoneal dialysis solutions.
The product is designed for medical use and is safe for patients with kidney disease when used as directed. It is not intended for general consumer use. Always consult with your healthcare provider before using any new product.
If you have concerns about the product, contact your healthcare provider or the manufacturer directly for assistance.
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-1365-2018 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-1365-2018 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.