Navilyst Medical, Inc. has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier. The Recall is classified as a Class 2 recall. The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion. This device is also indicated for injection of contrast media by a power injector only with power injectable implanted port. The NMI Port is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. Affected Batch/Lot Numbers and instructions for returning the device are found here.
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