This product is currently subject to recall. This recall was initiated due to material variations in the tubing used in the Continuum infusions sets that resulted in flow rate accuracy performance issues when used in conjunction with the Continuum pump. Bayer’s top priorities are patient safety and serving our customers. No patient injuries were reported as a result of this issue.
Bayer HealthCare is initiating a product removal. This is a voluntary decision, driven by technical, regulatory and manufacturing considerations and a desire to resolve the ongoing recall situation for our customers.
As Bayer completes local regulatory notifications and ensures that its removal program meets country legal and regulatory guidelines, the company will inform Continuum customers about the removal program process directly or, where applicable, through its local distributor. To ensure that sites have sufficient time to identify an alternative solution to their fluid delivery needs in the Magnetic Resonance Imaging suite, Bayer intends to complete the removal program no later than June 30, 2015. In some countries, based on local business practices this may occur sooner. Until such time as the product is removed from the local market, Bayer will continue to offer allocated infusion sets and pump preventive maintenance to customers currently receiving sets for use with Continuum at the interim maximum flow rate of 500 ml/hr.