Fresenius Optiflux F200A Dialyzers Recalled for Dialysate Port Leak
Fresenius Medical Care is recalling 5,244 Optiflux F200A dialyzers due to a dialysate port 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 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 hemodialysis, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 5,244 units of Optiflux F200A High Flux Dialyzers (Product Number: 0500320A). The affected units are identified by Lot Number 13NU04009. These single-use devices are intended for acute or chronic hemodialysis treatment.
The recall was initiated because the dialyzers may experience a dialysate port leak during the priming process. The affected products were distributed nationwide in the United States and in Mexico.
Healthcare providers and patients should stop using the affected dialyzers and contact Fresenius Medical Care for further instructions or replacement units.
The recalled product
- Product
- Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 5,244
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 Number: 13NU04009
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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