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.
What this means for you
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
Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Same hazard · temperature exposure
See all →- ModerateQuantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure
FDA (Devices) · 2024-10-30
- HighRespiratory inhalation medication recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- ModerateAllopurinol tablets recalled due to improper storage conditions
FDA (Drugs) · 2024-01-03
- HighPredniSONE Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateMeloxicam 15 mg tablets recalled for exposure to improper storage temperatures
FDA (Drugs) · 2024-01-03