Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a performance defect (flow rate accuracy) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets, including 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 product is a peristaltic pump system designed for patients who require medications and other fluids during an MR 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.
The recalled product
- 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 proc
- 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.
See all 11 products in this recall →Related recalls
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Same hazard · flow rate inaccuracy
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- HighBayer Recalls Medrad Continuum MR Infusion Pump Tubing Sets
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