Fresenius Medical Care North America Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
Brand
Fresenius Medical Care North America
Lot Codes / Batch Numbers
Lot # 7LU416
Products Sold
Lot # 7LU416
Fresenius Medical Care North America is recalling Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North A due to Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
Recommended Action
Per FDA guidance
Consignees were notified by telephone and certified letter , Urgent Device Recall, on 12/03/2007. They were told to discontinue use and to return all unused affected dialyzers to Fresenius.
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