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cGMP Deviations
General Motors, LLC (GM) is recalling certain 2025 Cadillac XT4 vehicles. The instrument panel may be missing the perforation on the underside of the panel cover that allows the passenger-side air bag to deploy properly.
Chrysler (FCA US, LLC) is recalling certain 2020-2023 Pacifica and 2020-2021, 2023 Voyager vehicles. An improperly secured connector for the side curtain air bags may prevent the air bags from deploying. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 214, "Side Impact Protection" and 226, "Ejection Mitigation."
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.
Newmar Corporation (Newmar) is recalling certain 2023-2025 Super Star motorhomes. The inner wheel tire valve extension may be damaged through contact with the outer wheels, causing the inner tire to lose air pressure and overload the outer tire.
Silver Eagle Manufacturing Company (Silver Eagle) is recalling certain eye and shank assemblies, models VAST20W, CTL40W, and CTA40W. The eye and shank welds may fatigue and crack, allowing and the eye to separate from trailer converter dolly.
Michelin North America, Inc. (Michelin) is recalling certain XVS and TRX specialty tires, provided as replacement tires for Recall 22T023. The DOT certification symbol is missing from the tire sidewalls. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 109, "New Pneumatic and Certain Specialty Tires," and 139, "New Pneumatic Radial Tires for Light Vehicles."
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.