Smiths Medical ASD Inc.: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

Agency Publication Date: October 13, 2021

Affected Products

Product: medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1

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Product: smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1

All codes

Product: smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076

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Product: smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081

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Product: smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082

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Product: smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083

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Product: smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084

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Product: smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090

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Product: smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

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Product: smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

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Product: smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

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Product: smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88667

Status: Resolved

Manufacturer: Smiths Medical ASD Inc.

Manufactured In: United States

Units Affected: 12 products (17980 units; 140 units; 3100 units; 10620 units; 870 units; 7080 units; 1420 units; 20 units; 20800 units; 150 units; 13620 units; 3620 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1

All codes

Product: smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1

All codes

Product: smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076

All codes

Product: smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081

All codes

Product: smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082

All codes

Product: smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083

All codes

Product: smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084

All codes

Product: smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090

All codes

Product: smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

All codes

Product: smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092

All codes

Product: smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

All codes

Product: smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094

All codes

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88667

Status: Resolved

Manufacturer: Smiths Medical ASD Inc.

Manufactured In: United States

Units Affected: 12 products (17980 units; 140 units; 3100 units; 10620 units; 870 units; 7080 units; 1420 units; 20 units; 20800 units; 150 units; 13620 units; 3620 units)