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The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
Forest River, Inc. (Forest River) is recalling certain 2020-2022 Cardinal fifth wheel recreational vehicles. The generator compartment may not be sealed properly, allowing carbon monoxide to enter the vehicle.