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Terminated

Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.

FDA Recall Z-1102-2014 · Posted 2014-02-26

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2014-02-04
Date Terminated2021-05-18
Product Quantity317,796 units

Reason for Recall

Dialysate Port Leak During Priming of the Dialyzers

Firm Action

Fresenius Medical issued Notice to Clinics and Clinics with Patients Letters Dated - 1st Mailing - February 4, 2014 and Patients Letters Dated - February 5, 2014 - these letters contained the correct information.Corrected letters to Clinics and Clinics with Patients issued 2/14/14 via certified mail with return receipt and fax-back form . Users are advised the leak may be stopped by tightening the dialysate port cap more securely. Questions associated with this product notification to your Customer Service Team at 1-800-323-5188.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution: USA (nationwide) and the country of: Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America · 2000-12-04

Official Source

View FDA Recall →

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

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