Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Reported: March 5, 2014 Initiated: February 4, 2014 #Z-1098-2014
Product Description
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Reason for Recall
Dialysate Port Leak During Priming of the Dialyzers
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 3,460,672 units
- Distribution
- Worldwide distribution: USA (nationwide) and the country of: Mexico.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 3,460,672 units.
Why was this product recalled? ▼
Dialysate Port Leak During Priming of the Dialyzers
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1098-2014.
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