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Terminated

Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N

FDA Recall Z-0333-06 · Posted 2005-12-31

Recalling FirmFresenius Medical Care North America
Recall StatusTerminated
Product CodeKDI
Date Initiated2005-11-28
Date Terminated2006-08-10

Reason for Recall

Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR

Firm Action

Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002277FRESENIUS OPTIFLUX 200NRFresenius Medical Care North America · 2000-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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