Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Fresenius Medical Care Holdings, Inc.
- Reason for Recall:
- Dialysate Port Leak During Priming of the Dialyzers
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1100-2014
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