Iantrek C-Rex UNO CRX-120 Goniotomy Instrument Recalled for Packaging Integrity Issue (2025)
Potential for compromised integrity of the sterile packaging.
Recall database
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.
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.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns