Loading...
Loading...
Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees.