Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate 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 is classified as FDA Class II. The hazard involves potential flow rate accuracy issues in a medical infusion device, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
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 involves 1,229 pumps total. Distribution was worldwide, including the USA (nationwide) and numerous international locations such as Australia, Canada, China, Germany, and Japan. 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 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 fun
- 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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