Draeger Atlan A350XL Anesthesia Workstation Recalled for Ventilator Failure Risk (223 Units) in 25+N
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
2,229 recalls tagged with “stop use immediately”.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Product contains undeclared milk and shrimp
Potential for compromised integrity of the sterile packaging.
Potential for compromised integrity of the sterile packaging.
cGMP deviations: Temperature excursion during transportation.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns