Recall Z-1100-2014— Fresenius Medical Care Holdings, Inc.
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-02-04, terminated 2021-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.. Reason: Dialysate Port Leak During Priming of the Dialyzers.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-04
- Terminated
- 2021-05-18
- Firm location
- Waltham, MA, United States
Product description
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
Reason for recall
Dialysate Port Leak During Priming of the Dialyzers
Data sourced from openFDA. This site is unofficial and independent of the FDA.