Reported Jan 15, 2025 · Ongoing
Dialyzer Optiflux 160NRe
Fresenius Medical Care Holdings, Inc.
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 Holdings, Inc. · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- Dialyzer Optiflux 160NRe
- Lot codes and dates
- UDI NUMBERS
24HU06011-00840861100149-27063024HU06010-00840861100149-270630
- Expiration date06/30/2027
- UDI NUMBERS
- Amount recalled
- 5,351 cases (64,212 dialyzers)
Where it was sold
- Nationwide
Why it was recalled
Potential for internal blood leaks due to cracked polyurethane
This product could cause temporary or reversible health problems — stop using it.
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