Fresenius Optiflux F200NRe Dialyzers Recalled for Dialysate Port Leak
Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.
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, and the defect involves a leak in a medical device used for hemodialysis, which poses a significant risk of harm to patients.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 317,796 units of Optiflux F200NRe High Flux Dialyzers (Product Number: 0500320E). 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 13LU04022, 13LU04021, 13NU04003, 13NU04005, 13NU04018, and 13SU04002. The products were distributed nationwide in the United States and in Mexico. This is classified as an FDA Class II recall.
Healthcare facilities and patients should stop using the affected dialyzers and contact Fresenius Medical Care for instructions on returns or replacements. Patients currently using these devices should consult their healthcare provider regarding the recall and any necessary precautions.
The recalled product
- Product
- Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 317,796
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: 13LU04022 13LU04021 13NU04003 13NU04005 13NU04018 13SU04002
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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