Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
FDA Recall Z-0738-2008 · Posted 2008-02-01
Recalling FirmFresenius Medical Care North America
Recall StatusTerminated
Product CodeKDI
Date Initiated2007-12-03
Date Terminated2008-02-08
Product Quantity2,791 cases (33,492 dialyzers)
Reason for Recall
Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.