Medrad Inc: Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

Agency Publication Date: December 20, 2012

Affected Products

Product: Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Material numbers 3009135, 3015550, and 3013365. See firm's website - www.medrad.com for specific serial and lot numbers.

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Product: Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Standard Kit: MIK 200A. See firm's website - www.medrad.com for specific serial and lot numbers.

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Product: Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Secondary Kit: MIL 200B. See firm's website - www.medrad.com for specific serial and lot numbers.

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Product: Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Primary Set: 3015153. See firm's website - www.medrad.com for specific serial and lot numbers.

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Product: Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Primary VSA Stopcock Set: 3015156. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Product: Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Primary VSA Set: 3015157. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Product: Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Primary Spike Set: 3015158. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Product: Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Secondary Set: 3015155. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Product: Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Secondary Spike Set: 3015160. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Product: Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Secondary VSA Set: 3015161. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Product: Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

Catalog number - Side Step Set: 3015159. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 61734

Status: Resolved

Manufacturer: Medrad Inc

Manufactured In: United States

Units Affected: 11 products (1,229 Pumps total)

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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

Material numbers 3009135, 3015550, and 3013365. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

numbers

Catalog number - Standard Kit: MIK 200A. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Secondary Kit: MIL 200B. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Primary Set: 3015153. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Primary VSA Stopcock Set: 3015156. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Primary VSA Set: 3015157. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Primary Spike Set: 3015158. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Secondary Set: 3015155. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Secondary Spike Set: 3015160. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Secondary VSA Set: 3015161. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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Catalog number - Side Step Set: 3015159. See firm's website - www.medrad.com for specific serial and lot numbers.

Lot Numbers:

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