Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis.
FDA Recall Z-1951-2010 · Posted 2010-07-01
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Recalling FirmFresenius Medical Care North America
Recall StatusTerminated
Product CodeKDI
Date Initiated2010-05-14
Date Terminated2011-09-13
Product Quantity34,152 units
Reason for Recall
Hemodialyzer may leak at the header/end cap
Firm Action
Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution
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.
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