Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
FDA device recall Z-1098-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Dialysate Port Leak During Priming of the Dialyzers
- Action taken
- 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
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 3,460,672 units
- Distribution
- Worldwide distribution: USA (nationwide) and the country of: Mexico.
- Date initiated
- 2014-02-04
- Date posted
- 2014-02-26
- Date terminated
- 2021-05-18
- Location
- Waltham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (K002761) | Fresenius Medical Care North America | 2000-12-04 |