Fresenius Recalls Optiflux F18Nre Dialyzers Due to Port Leak Risk
Fresenius Medical Care is recalling 34,752 Optiflux F18Nre Flux Dialyzers because the dialysate port may leak during priming.
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 that poses a risk of harm (leakage) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 34,752 units of Optiflux F18Nre Flux Dialyzers, Product Number 0500308E. These single-use devices are intended for acute or chronic hemanalysis treatment.
The recall was initiated because the dialysate port may leak during the priming of the dialyzers. The affected units are identified by Lot Number 13PU03011.
The products were distributed nationwide in the United States and in Mexico. Healthcare providers and patients should stop using the affected dialyzers and contact the manufacturer for further instructions.
The recalled product
- Product
- Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 34,752
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 Number: 13PU03011
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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