Fresenius Medical Care Holdings, Inc. Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Brand
Fresenius Medical Care Holdings, Inc.
Lot Codes / Batch Numbers
UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
Products Sold
UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
Fresenius Medical Care Holdings, Inc. is recalling Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E due to Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedur. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Recommended Action
Per FDA guidance
A Customer Notification was sent to the five (5) affected consignees on 05/04/2022 via USPS First Class Mail. The firm also followed up with phone calls with consignees with instructions to examine their stock to determine whether they have affected product on hand, and to remove product from their inventory.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026