Agency classClass IIOur severity:High FDA (Devices)·Z-1099-2014·Announced 2014-03-05

Fresenius Optiflux F160NR Dialyzers Recalled for Dialysate Port Leak

Fresenius Medical Care is recalling Optiflux F160NR dialyzers because the dialysate port may leak during priming. The recall covers 6,720 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, and the hazard involves a leak in a medical device used for dialysis, which poses a risk of harm without reported injuries or fatalities in the source text.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 6,720 units of Optiflux F160NR High Flux Dialyzers (Product Number: 0500316N). These single-use devices are intended for acute or chronic hemodialysis treatment. The recall is due to a defect where the dialysate port may leak during the priming process.

The affected lots are 13NU01014, 13SU01001, and 13SU01002. The products were 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 cause temporary or medically reversible health consequences.

Healthcare facilities and patients should stop using the affected dialyzers and contact Fresenius Medical Care for instructions on return or replacement. No specific instructions for individual consumers are provided in the source text, but patients should consult their healthcare providers regarding the recall.

The recalled product

Product: Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Equipment
Hazard: leak
device-defect
Affected units: 6,720

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: 13NU01014 13SU01001 13SU01002

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 →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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