Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
This recall has been terminated (originally issued February 26, 2014).
- Recall Initiated
- February 4, 2014
- Posted
- February 26, 2014
- Terminated
- May 18, 2021
- Recall Number
- Z-1105-2014
- Quantity
- 100,008 units
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Dialysate Port Leak During Priming of the Dialyzers
Distribution
Worldwide distribution: USA (nationwide) and the country of: Mexico.
Lot / Code Info
Lot Numbers: 13LU02011 13LU02013 13NU02016 13NU02017
Root Cause
Under Investigation by firm
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.