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 defect that may result in flow rate accuracy issues, posing 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 where injury has not yet been reported.
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. These products are peristaltic pump systems designed for patients requiring medications and fluids during MR procedures.
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 1,229 pumps total distributed worldwide, including the United States and numerous international locations. Specific serial and lot numbers can be found on the firm's website. Healthcare providers and consumers should stop using the affected tubing sets and contact the manufacturer for further instructions.
The recalled product
- 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
- 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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