Fresenius Optiflux 200NRe Dialyzers Recalled Due to Temperature Exposure
Fresenius Medical Care is recalling 19 cases of Optiflux 200NRe dialyzers distributed in Pennsylvania after exposure to cold temperatures outside safe storage ranges. Affected lot number is 22AU04017.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II precautionary recall without any reported illnesses, injuries, or hospitalizations. The hazard is a quality control issue related to storage conditions, without documented patient harm.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Optiflux 200NRe Dialyzer Finished Assembly (Model 0500320E). The recall involves 19 cases distributed in Pennsylvania with lot number 22AU04017.
The dialyzers were distributed after being exposed to cold temperatures that exceeded the temperature ranges specified in the manufacturer's standard operating procedures. This storage condition may have affected the integrity or function of the devices.
If you have received dialyzers from this lot, contact Fresenius Medical Care Holdings, Inc. for instructions. Do not use affected units until you have received guidance from the manufacturer or your healthcare provider.
The recalled product
- Product
- Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Dialyzers
- Hazard
- Affected units
- 19
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)
- UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
Distribution
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