FDAFDA · Food and drugs·Recall number Z-1099-2014
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
Published March 5, 2014 · Recall initiated: February 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Dialysate Port Leak During Priming of the Dialyzers
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Worldwide distribution: USA (nationwide) and the country of: Mexico.
- Lot
- Lot Numbers: 13NU01014 13SU01001 13SU01002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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