Fresenius Optiflux F180NR Dialyzers Recalled for Dialysate Port Leak
Fresenius Medical Care is recalling Optiflux F180NR dialyzers due to a dialysate port leak during priming. The recall covers 52,752 units distributed in the US and Mexico.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a leak in a medical device used for dialysis, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Optiflux F180NR High Flux Dialyzers, Product Number 0500318N. These single-use devices are intended for acute or chronic hemodialysis treatment. The recall involves 52,752 units distributed nationwide in the United States and in Mexico.
The recall is being conducted because the dialysate port may leak during the priming of the dialyzers. The affected lot numbers are 13NU03003, 13NU03010, 13PU04010, and 13SU03001.
Healthcare facilities and consumers should stop using the affected dialyzers and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 52,752
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 (1)
- Lot Numbers: 13NU03003 13NU03010 13PU04010 13SU03001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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