Class I - Dangerous
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Intersurgical
11 recalls • • Categories: Other Medical Devices, Surgical Instruments, Infusion Pumps
Class I - Dangerous
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Class I - Dangerous
Potential for faulty devices as a result of depleted batteries.
Class I - Dangerous
Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient
The device was assembled with the incorrect exhalation port which can cause gas leakage.
Class I - Dangerous
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class I - Dangerous
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class I - Dangerous
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class I - Dangerous
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Class I - Dangerous
When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.