Fresenius Optiflux F200NR Dialyzers Recalled for Dialysate Port Leak
Fresenius Medical Care is recalling 19,596 Optiflux F200NR dialyzers due to a dialysate port leak during priming. The units were 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 involves a medical device defect (dialysate port leak) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 19,596 units of Optiflux F200NR High Flux Dialyzers, Product Number 0500320N. These single-use devices are intended for acute or chronic hemanalysis treatment. The recall is limited to Lot Number 13NU04008.
The recall was initiated because the dialyzers may experience a dialysate port leak during the priming process. The affected units were distributed nationwide in the United States and in Mexico.
Healthcare facilities and patients should stop using the affected dialyzers and contact Fresenius Medical Care for further instructions or replacement units.
The recalled product
- Product
- Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 19,596
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 Number: 13NU04008
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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