Class I - Dangerous
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Integra LifeSciences Corp. (NeuroSciences)
18 recalls • • Categories: Other Medical Devices, Surgical Instruments, Infusion Pumps
Class I - Dangerous
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Class I - Dangerous
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Class I - Dangerous
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I - Dangerous
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I - Dangerous
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I - Dangerous
Lack of sterility assurance.
Class I - Dangerous
Inadequate weld that can potentially cause the product to disassemble.
Class I - Dangerous
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Class I - Dangerous
Inadequate weld that can potentially cause the product to disassemble.