Reported Mar 5, 2014 · Terminated
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
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 · Waltham, MA · 02451-1521
Is this the product you have?
- Optiflux F160NRe High Flux Dialyzers
- Product Number0500316E. Single Use acute or chronic hemanalysis treatment
- Lot codes and dates
- Lot Numbers
125 of 125 codes
13LU0100113KU0501813LU0500113KU0602613LU0600113LU0600213LU0500213LU0600313LU0100713LU0100813LU0100913LU0500313LU0500413LU0500513LU0500613LU0500713LU0500813LU0600413LU0600513LU0600613LU0600813LU0600913LU0601013LU0601113LU0601213LU0601313LU0601413LU0601513LU0601613LU0101013LU0101113LU0601713LU0601813LU0101213LU0101313LU0501413LU0601913LU0602013LU0602113LU0101513LU0501513LU0602213NU0500213NU0600213NU0100413NU0500313NU0600313NU0600413NU0600713NU0100513NU0100613NU0100713NU0100813NU0600813NU0600913NU0601013NU0601113NU0601213NU0601313NU06014
- Lot Numbers
- Amount recalled
- 3,460,672 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Dialysate Port Leak During Priming of the Dialyzers
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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