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Non-Sterility
Failed Impurities/Degradation Specifications
Possibility that the user is unable to resolve drill disconnection error messages.
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.
Nova Bus (US) Inc. (Nova Bus) is recalling certain 2021-2023 LFS transit buses equipped with a directional foot switch. The turn signals may intermittently become inoperative.
Nova Bus (US) Inc. (Nova Bus) is recalling certain 2020-2023 LFS and LFS Artic transit buses. The brackets retaining the Mobile Climate Control HVAC Unit could fail and allow the unit to detach from the bus.
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Xos, Inc (Xos) is recalling certain 2021-2022 SV05 and 2021 SA01 vehicles. The bolts and brackets connecting the hardware to the electronic parking brake system may come loose, causing the parking brake to fail.
Prevost Car (US) Inc. (Prevost) is recalling certain 2024 H3-45, 2023-2024 H3-45 VIP, X3-45 VIP, X3-45 VIP Entertainer, and 2023 X3-45 motor coaches. The grid heater cables that connect to the relay may have a loose connection and cause the relay to overheat.
Due to incorrect product/device within packaging.