Optiflux 200NRe Dialyzer Finished Assy recall
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Why was Optiflux 200NRe Dialyzer Finished Assy recalled?
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
- Product
- Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 19 cases
- Distribution
- US Nationwide distribution in the state of Pennsylvania.
- Recall date
- July 6, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)