Medical device manufacturer, MEDRAD, Inc. has initiated a field safety corrective actions concerning MEDRAD® Continuum Pump and Tubing Set [Catalogue numbers: MIK 200A, MIL 200B, 3009135, 3015550, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159 and 3015161].
The recall is initiated because the tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.
In addition, the manufacturer is also recalling the Continuum pumps, calibrated using the tubing associated with this recall.
For those serial numbers not affected by this recall, users are advised to follow the instructions enclosed to reset the maximum flow rate of their Continuum pump(s) for future operation with the new tubing.
According to the local supplier, the affected devices have been distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for necessary actions.