smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

Reason: Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Code information: UDI/DI 35021239002593, Lot Numbers: 0003373, 0003456, 0003621, 0003374, 0003376, 0003375, 0003459, 0003391, 0003480, 0003549, 0003301, 0003124, 0003130, 0003139, 0003140, 0003144, 0003148, 0003152, 0003161, 0003169, 0003185, 0003205, 0003210, 0003222, 0003232, 0003236, 0003255, 0003276, 0003277, 0003315, 0003329, 0003339, 0003367, 0003370, 0003371, 0003372, 0003381, 0003395, 0003399, 0003403, 0003414, 0003449, 0003457, 0003469, 0003476, 0003477, 0003489, 0003492, 0003500, 0003573, 0003484, 0003619, 0003557, 0003510, 0003522, 0003597, 0003511, 0003622, 0003553, 0003581, 0003605, 0003529,

Distribution pattern: Worldwide distribution.