Optiflux F180NRe High Flux Dialyzers
Medical device recall Z-1100-2014. Published in FDA’s Enforcement Report on Mar 5, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 5, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3,744,122 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Dialysate Port Leak During Priming of the Dialyzers
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
3,744,122, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: 13LU02004 13LU02005 13LU02008 13LU03006 13LU03007 13LU03008 13LU04005 13LU04006 13LU04007 13LU04008 13LU04009 13LU04010 13LU03009 13LU03010 13LU03011 13LU03012 13LU04011 13LU04012 13LU03014 13LU02018 13LU03015 13LU03016…
Every code shown here, 1,152 characters
Lot Numbers: 13LU02004 13LU02005 13LU02008 13LU03006 13LU03007 13LU03008 13LU04005 13LU04006 13LU04007 13LU04008 13LU04009 13LU04010 13LU03009 13LU03010 13LU03011 13LU03012 13LU04011 13LU04012 13LU03014 13LU02018 13LU03015 13LU03016 13LU03017 13LU03018 13NU03001 13NU02001 13NU03002 13NU03004 13NU03005 13NU02005 13NU02006 13NU02007 13NU03006 13NU03007 13NU03008 13NU03009 13NU05006 13NU05007 13NU05009 13NU03011 13NU03012 13NU04011 13NU05016 13NU05017 13NU05018 13NU03018 13NU04017 13PU02003 13NU03019 13PU03001 13PU03002 13PU03003 13PU05002 13PU05003 13PU02004 13PU02005 13PU02006 13PU02007 13PU03004 13PU03006 13PU03007 13PU03008 13PU05004 13PU02010 13PU02011 13PU02012 13PU03010 13PU04011 13PU04012 13PU04013 13PU05009 13PU05010 13PU05011 13PU02013 13PU02014 13PU02015 13PU02016 13PU02017 13PU03013 13PU03014 13PU03015 13PU03016 13PU03017 13PU04014 13PU05016 13PU05017 13SU05001 13SU02003 13SU03004 13SU02004 13NU04012 13NU05010 13NU05011 13NU02012 13NU02013 13NU02014 13NU03016 13NU03017 13NU04015 13NU04016 13NU05014 13NU05015 13PU04015 13PU04016 13PU04017 13PU04018 13PU05012 13PU05013 13PU05014 13PU05015 13PU02018 13PU02019 13SU02001 13PU04019
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution: USA (nationwide) and the country of: Mexico.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 4, 2014.
- FDA classified it on Feb 26, 2014.
- FDA’s Enforcement Report published it on Mar 5, 2014.
- FDA terminated it on May 18, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Holdings, Inc., of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.