Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 13LU01001 13KU05018 13LU05001 13KU06026 13LU06001 13LU06002 13LU05002 13LU06003 13LU01007 13LU01008 13LU01009 13LU05003 13LU05004 13LU05005 13LU05006 13LU05007 13LU05008 13LU06004 13LU06005 13LU06006 13LU06008 13LU06009 13LU06010 13LU06011 13LU06012 13LU06013 13LU06014 13LU06015 13LU06016 13LU01010 13LU01011 13LU06017 13LU06018 13LU01012 13LU01013 13LU05014 13LU06019 13LU06020 13LU06021 13LU01015 13LU05015 13LU06022 13NU05002 13NU06002 13NU01004 13NU05003 13NU06003 13NU06004 13NU06007 13NU01005 13NU01006 13NU01007 13NU01008 13NU06008 13NU06009 13NU06010 13NU06011 13NU06012 13NU06013 13NU06014 13NU01009 13NU01010 13NU06015 13NU06016 13NU06017 13NU06018 13NU06020 13NU06021 13NU06022 13NU06023 13NU06024 13NU06025 13NU06026 13NU06027 13NU01015 13NU01016 13NU01017 13NU01018 13PU01001 13PU01002 13PU01003 13NU06029 13PU06001 13PU06002 13PU06018 13PU01013 13PU01014 13PU01015 13PU01017 13PU06019 13PU06020 13PU06021 13PU06022 13PU06023 13PU06024 13PU06025 13PU06026 13PU06027 13PU06028 13SU06004 13SU06005 13LU06023 13LU06024 13LU06025 13LU06027 13LU06028 13NU06001 13LU05016 13LU01016 13LU01017 13NU01001 13LU05017 13NU01002 13PU06003 13PU01004 13PU01007 13PU06006 13PU06007 13PU01008 13PU01010 13PU01011 13PU01012 13PU06015 13PU06016 13PU06017
- 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 F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Product Codes/Lot Numbers:
Lot Numbers: 13LU01001 13KU05018 13LU05001 13KU06026 13LU06001 13LU06002 13LU05002 13LU06003 13LU01007 13LU01008 13LU01009 13LU05003 13LU05004 13LU05005 13LU05006 13LU05007 13LU05008 13LU06004 13LU06005 13LU06006 13LU06008 13LU06009 13LU06010 13LU06011 13LU06012 13LU06013 13LU06014 13LU06015 13LU06016 13LU01010 13LU01011 13LU06017 13LU06018 13LU01012 13LU01013 13LU05014 13LU06019 13LU06020 13LU06021 13LU01015 13LU05015 13LU06022 13NU05002 13NU06002 13NU01004 13NU05003 13NU06003 13NU06004 13NU06007 13NU01005 13NU01006 13NU01007 13NU01008 13NU06008 13NU06009 13NU06010 13NU06011 13NU06012 13NU06013 13NU06014 13NU01009 13NU01010 13NU06015 13NU06016 13NU06017 13NU06018 13NU06020 13NU06021 13NU06022 13NU06023 13NU06024 13NU06025 13NU06026 13NU06027 13NU01015 13NU01016 13NU01017 13NU01018 13PU01001 13PU01002 13PU01003 13NU06029 13PU06001 13PU06002 13PU06018 13PU01013 13PU01014 13PU01015 13PU01017 13PU06019 13PU06020 13PU06021 13PU06022 13PU06023 13PU06024 13PU06025 13PU06026 13PU06027 13PU06028 13SU06004 13SU06005 13LU06023 13LU06024 13LU06025 13LU06027 13LU06028 13NU06001 13LU05016 13LU01016 13LU01017 13NU01001 13LU05017 13NU01002 13PU06003 13PU01004 13PU01007 13PU06006 13PU06007 13PU01008 13PU01010 13PU01011 13PU01012 13PU06015 13PU06016 13PU06017
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1098-2014
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