Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets due to a variation that may cause flow rate accuracy issues when used with Continuum pumps.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential flow rate accuracy issues without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets, including both macrobore and microbore types. The affected catalog numbers are MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161.
The firm is initiating this recall because the tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. The Medrad Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure, providing infusion therapy directly prior to, during, and immediately after the procedure.
The recall covers 1,229 pumps total with worldwide distribution, including the United States and numerous international locations. Specific serial and lot numbers can be found on the firm's website at www.medrad.com. Users should check their equipment against the listed catalog numbers and contact the manufacturer for further instructions.
The recalled product
- 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 funct
- Manufacturer
- Medrad Inc
- Hazard
- Affected units
- 1,229
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medrad Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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