All Recalls

CGMP Deviations

CGMP Deviations

CGMP Deviations

cGMP deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

CGMP Deviations

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

CGMP Deviations

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.