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.
Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 142327 units Lot/code info: REF 14-504-17, UDI/DI 35021239002579, Lot Numbers: 0003340, 0003620, 0003616, 0003580, 0003542, 0003509, 0003579, 0003568, 0003599, 0003615, 0003589, 0003562, 0003601, 0003618, 0003583, 0003613, 0003270, 0003629, 0003293, 0003584, 0003487, 0003617, 0003280, 0003348, 0003470, 0003523, 0003607, 0003576, 0003422, 0003614, 0003633, 0003578, 0003630, 0003207, 0003438, 0003559, 0003570, 0003478, 0003533, 0003588, 0003433, 0003556, 0003561, 0003446, 0003284, 0003545, 0003461, 0003590, 0003398, 0003530, 0003539, 0003550, 0003213, 0003598, 0003623, 0003504, 0003548, 0003552, 0003631, 0003594, 0003625, 0003600, 0003378, 0003526, 0003574, 0003411, 0003471, 0003587, 0003596, 0003297, 0003298, 0003412, 0003424, 0003425, 0003517, 0003151, 0003163, 0003235, 0003347, 0003350, 0003382, 0003390, 0003416, 0003423, 0003603, 0003638, 0003641, 0003175, 0003214, 0003238, 0003253, 0003257, 0003343, 0003351, 0003388, 0003397, 0003428, 0003486, 0003488, 0003496, 0003498, 0003528, 0003541, 0003608, 0003610, 0003612, 0003639, 0003640, 0003121, 0003122, 0003123, 0003125, 0003126, 0003127, 0003128, 0003129, 0003131, 0003132, 0003133, 0003134, 0003135, 0003136, 0003137, 0003138, 0003141, 0003142, 0003143, 0003145, 0003146, 0003147, 0003149, 0003150, 0003153, 0003154, 0003155, 0003156, 0003157, 0003158, 0003159, 0003160, 0003164, 0003166, 0003167, 0003168, 0003170, 0003171, 0003172, 0003173, 0003174, 0003176, 0003177, 0003178, 0003179, 0003180, 0003181, 0003182, 0003183, 0003188, 0003190, 0003191, 0003192,
35021239002579
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.