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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- 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.
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