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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Potential that the measured value may be smaller than the actual area.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.