Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Reported: December 26, 2018 Initiated: November 5, 2018 #Z-0658-2019
Product Description
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Reason for Recall
Potential for external blood leaks from the dialyzer header
Details
- Recalling Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Units Affected
- 9,097 cs x 12 units each
- Distribution
- US Nationwide
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 9,097 cs x 12 units each.
Why was this product recalled? ▼
Potential for external blood leaks from the dialyzer header
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0658-2019.
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