Bayer Recalls Medrad Continuum MR Infusion Pump 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 where a defect may result in flow rate accuracy performance issues, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets, including both macrobore and microbore types. The specific catalog numbers affected 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 Pump 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 with worldwide distribution, including the United States and numerous international locations. Consumers and healthcare providers should check their inventory for the listed catalog numbers and contact the firm for further instructions.
The recalled product
- Product
- Medrad(R) Continuum MR Infusion Pump 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 functioning while eit
- Manufacturer
- Medrad Inc
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 1,229
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Material numbers 3009135
- 3015550
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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