Reported Mar 5, 2014 · Terminated
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. 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 F180NRe High Flux Dialyzers
- Product Number0500318E. Single Use acute or chronic hemanalysis treatment
- Lot codes and dates
- Lot Numbers
114 of 114 codes
13LU0200413LU0200513LU0200813LU0300613LU0300713LU0300813LU0400513LU0400613LU0400713LU0400813LU0400913LU0401013LU0300913LU0301013LU0301113LU0301213LU0401113LU0401213LU0301413LU0201813LU0301513LU0301613LU0301713LU0301813NU0300113NU0200113NU0300213NU0300413NU0300513NU0200513NU0200613NU0200713NU0300613NU0300713NU0300813NU0300913NU0500613NU0500713NU0500913NU0301113NU0301213NU0401113NU0501613NU0501713NU0501813NU0301813NU0401713PU0200313NU0301913PU0300113PU0300213PU0300313PU0500213PU0500313PU0200413PU0200513PU0200613PU0200713PU0300413PU03006
- Lot Numbers
- Amount recalled
- 3,744,122
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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