Recall Z-1105-2014 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
| Date | Feb 26, 2014 (initiated Feb 4, 2014) |
| Status | Terminated |
| Reason | Dialysate Port Leak During Priming of the Dialyzers |
| Root cause | Under Investigation by 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. |
| Quantity | 100,008 units |
| Distribution | Worldwide distribution: USA (nationwide) and the country of: Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082414 | OPTIFLUX F250NR, MODEL 0500325E Fresenius Medical Care North America, Oct 28, 2008 |