Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
Hazard
Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
What You Should Do
Remedy
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.
Affected by this recall?
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Products
Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
- Brand
- Fresenius Medical Care North America
- UPC
- Lot # 7LU416
Units Affected
2,791 cases (33,492 dialyzers)