Reported Jul 6, 2022 · Terminated
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
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 950 · Waltham, MA · 02451-1521
Is this the product you have?
Optiflux 200NRe Dialyzer Finished AssyModel no. 0500320E
- Lot codes and dates
- UDI-DI (GTIN)(01)00840861100163 Lot 22AU04017
- Amount recalled
- 19 cases
Where it was sold
- Nationwide
- PA
Why it was recalled
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
This product could cause temporary or reversible health problems — stop using it.
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