Reported Dec 26, 2018 · Terminated
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
- Lot codes and dates
- Lot Numbers
18HU0601618HU0601718HU06018 and 18HU06019
- Lot Numbers
- Amount recalled
- 9,097 cs x 12 units each
Where it was sold
- Nationwide
Why it was recalled
Potential for external blood leaks from the dialyzer header
This product could cause temporary or reversible health problems — stop using it.
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