Lower riskMedical device recall · FDA · Published January 24, 2018
Fresenius Medical Care - Renal Therapies Group, LLC
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.
Take action
Contact the company
📍Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/72108-fresenius-medical-care-renal-therapies-group-llc.
“Fresenius Medical Care - Renal Therapies Group, LLC.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72108-fresenius-medical-care-renal-therapies-group-llc. Based on FDA recall #Z-1365-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1365-2018%22&limit=1).
Fresenius Medical Care Renal Therapies Group, LLC has voluntarily recalled specific lots of Class II medical devices following a safety notice from the FDA.
How to tell if you have it
Fresenius Medical Care Renal Therapies Group, LLC
FDA
The hazard
The recall involves various hazards associated with different Fresenius products, including the risk of blood leak during treatment, blue-green discoloration in dry acid concentrate, dialysate leaks posing a slip and fall hazard, and general communication issues regarding treatment preparation instructions.
Context
Fresenius Medical Care Renal Therapies Group, LLC has 15 other recalls on record since 2017-09-29. Recent related notices include a 2026-08-10 recall for the 5008X Blood Tubing Set due to blood leak risks, a 2026-07-29 recall for CombiSet Hemodialysis Tubing Sets regarding instruction review, and a 2026-07-14 recall for GRANUFLO Dry Acid Concentrate due to discoloration complaints.
How to tell if you have this one
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.
Brand
Fresenius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
1
Verify the product label to ensure it matches the intended use for patients with kidney disease.
2
Check the expiration date on the product label to ensure it is within the valid period.
3
Consult with a healthcare provider to confirm the product is appropriate for your specific condition.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 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-1365-2018 (January 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1365-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 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.