Recalls / —
—#125231
Product
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
- FDA product code
- KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K002277
- Affected lot / code info
- Lot Numbers: 13NU01014 13SU01001 13SU01002
Why it was recalled
Dialysate Port Leak During Priming of the Dialyzers
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Address
- 920 Winter St, Waltham, Massachusetts 02451-1521
Distribution
- Distribution pattern
- Worldwide distribution: USA (nationwide) and the country of: Mexico.
Timeline
- Recall initiated
- 2014-02-04
- Posted by FDA
- 2014-02-26
- Terminated
- 2021-05-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.