Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets
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 defect that may result in flow rate accuracy performance issues, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
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 source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The recall covers the tubing sets listed above. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, nor does it specify the total number of units affected or the specific distribution locations for this particular recall action.
The recalled product
- 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 funct
- Manufacturer
- Medrad Inc
- Category
- Medical Device — Infusion System
- 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
See all →- HighMedrad Continuum MR Infusion System tubing sets recalled for flow rate issues
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- HighMedrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
FDA (Devices) · 2012-12-26
- HighBayer Recalls Medrad Continuum MR Infusion Pump Tubing Sets
FDA (Devices) · 2012-12-26