Fresenius Optiflux Dialyzers Recalled for Dialysate Port Leak During Priming
Fresenius Medical Care is recalling Optiflux F160NRe dialyzers because the dialysate port may leak during priming. The recall covers 3.4 million 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 FDA classified this as a Class II recall, and the hazard involves a leak in a medical device used for dialysis, which poses a risk of harm to patients even though specific injuries are not detailed in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Optiflux F160NRe High Flux Dialyzers (Product Number: 0500316E) because the dialysate port may leak during the priming process. The affected units are intended for single-use acute or chronic hemodialysis treatment.
The recall involves 3,460,672 units distributed nationwide in the United States and in Mexico. The FDA has classified this recall as Class II, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
Healthcare facilities and distributors should stop using the affected dialyzers and contact Fresenius Medical Care for instructions on how to return or dispose of the units. Patients should consult their healthcare providers if they have questions about the recall or their dialysis treatment.
The recalled product
- Product
- Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 3,460,672
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.
See all 9 products in this recall →Related recalls
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