Peritoneal Dialysis Solution Recalled for Tube Weld Failure Risk
Fresenius is recalling DELFLEX dialysis solution due to tube weld failures causing slow leaks that are difficult to detect. 183 cases affected nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a confirmed manufacturing defect (tube weld failure) in a sterile medical solution for peritoneal dialysis. The defect poses a risk of contamination in a critical medical procedure where no illnesses or injuries have been reported, meeting the criteria for a risk-of-harm product.
Plain-English summary
DELFLEX peritoneal dialysis solution (batch 24AU03024, expiration 07/31/2025) is being recalled by Fresenius Medical Care Holdings due to tube weld failures. These failures result in slow leaks that may be difficult to detect.
The recalled product comprises 183 cases distributed nationwide. DELFLEX is a sterile dialysis solution used for peritoneal dialysis, a form of kidney replacement therapy.
Patients and healthcare providers should discontinue use of the recalled batches and contact the manufacturer or their healthcare provider for information about product replacement.
The recalled product
- Product
- DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
- Brand
- DELFLEX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- weld-failure
- leak
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 24AU03024
- exp. date 07/31/2025
Distribution
Distributed nationwide across the United States.
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