Agency classClass IIOur severity:Severe FDA (Devices)·Z-1105-2014·Announced 2014-03-05

Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk

Fresenius Medical Care is recalling 100,008 Optiflux B200 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving medical devices where defects could lead to significant injury or property damage, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 100,008 units of Optiflux B200 Flux Dialyzers, Product Number 0500325E. These single-use devices are intended for acute or chronic hemanalysis treatment. The recall involves specific lot numbers: 13LU02011, 13LU02013, 13NU02016, and 13NU02017.

The recall was initiated because the dialysate port may leak during the priming of the dialyzers. This defect could compromise the integrity of the device during use. The affected products were distributed worldwide, including nationwide in the United States and in Mexico.

Healthcare facilities and distributors should stop using the affected dialyzers immediately. Users should contact Fresenius Medical Care for instructions on returning the devices or obtaining replacements. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product: Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Equipment
Hazard: leak
device-defect
Affected units: 100,008

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: 13LU02011 13LU02013 13NU02016 13NU02017

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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