Class 2 Device Recall Portex

• Date Initiated by Firm: October 28, 2024
• Date Posted: November 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0527-2025
• Recall Event ID: 95605
• Product Classification: Stylet, tracheal tube - Product Code BSR
• Product: smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
• Code Information: 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, 0003193, 0003194, 0003195, 0003197, 0003198, 0003199, 0003200, 0003201, 0003202, 0003203, 0003208, 0003209, 0003211, 0003212, 0003215, 0003217, 0003219, 0003220, 0003221, 0003223, 0003224, 0003225, 0003227, 0003228, 0003229, 0003230, 0003231, 0003233, 0003234, 0003237, 0003239, 0003240, 0003241, 0003242, 0003243, 0003244, 0003245, 0003246, 0003247, 0003248, 0003249, 0003250, 0003251, 0003252, 0003258, 0003259, 0003260, 0003261, 0003262, 0003263, 0003264, 0003265, 0003266, 0003268, 0003269, 0003271, 0003272, 0003273, 0003274, 0003275, 0003278, 0003279, 0003281, 0003282, 0003283, 0003285, 0003286, 0003287, 0003288, 0003289, 0003290, 0003291, 0003292, 0003294, 0003295, 0003296, 0003299, 0003302, 0003303, 0003304, 0003305, 0003306, 0003309, 0003310, 0003311, 0003312, 0003313, 0003316, 0003317, 0003318, 0003319, 0003320, 0003321, 0003323, 0003324, 0003325, 0003326, 0003327, 0003328, 0003330, 0003331, 0003332, 0003333, 0003334, 0003335, 0003336, 0003337, 0003338, 0003341, 0003342, 0003344, 0003345, 0003346, 0003349, 0003352, 0003353, 0003354, 0003355, 0003356, 0003365, 0003366, 0003379, 0003383, 0003384, 0003385, 0003386, 0003387, 0003389, 0003392, 0003396, 0003400, 0003401, 0003402, 0003404, 0003405, 0003406, 0003407, 0003408, 0003409, 0003410, 0003413, 0003417, 0003418, 0003419, 0003420, 0003421, 0003426, 0003427, 0003429, 0003430, 0003431, 0003432, 0003434, 0003435, 0003436, 0003437, 0003439, 0003440, 0003441, 0003442, 0003443, 0003444, 0003445, 0003447, 0003448, 0003450, 0003451, 0003452, 0003453, 0003454, 0003455, 0003458, 0003460, 0003462, 0003463, 0003464, 0003465, 0003466, 0003467, 0003468, 0003472, 0003473, 0003474, 0003475, 0003479, 0003481, 0003482, 0003485, 0003490, 0003491, 0003493, 0003494, 0003495, 0003497, 0003499, 0003501, 0003502, 0003503, 0003505, 0003506, 0003507, 0003508, 0003512, 0003513, 0003514, 0003515, 0003516, 0003518, 0003519, 0003520, 0003521, 0003524, 0003525, 0003527, 0003531, 0003532, 0003534, 0003535, 0003536, 0003537, 0003538, 0003543, 0003544, 0003547, 0003551, 0003554, 0003560, 0003565, 0003566, 0003582, 0003586, 0003591, 0003592, 0003593, 0003595, 0003602, 0003604, 0003606, 0003611, 0003624, 0003632, 0003636, 0003637, 0003642, 0003575, 0003540, 0003572, 0003558, 0003555, 0003567, 0003585, 0003546, 0003609, 0003564, 0003563, 0003571, 0003577, 0003569; REF 14-504-17JP, UDI/DI 35021239002579, Lot Numbers: 0003215, 0003415, 0003483
• FEI Number: 3012307300
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: 763-383-3072
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Smiths Medical issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 10/28/2024, mailed using a traceable means. The notice explained the issue, potential risk, and requested the consignee locate and destroy all affected products, and distribute the notice to all affected parties. Distributors were directed to notify their customers. For questions: About the communication: smithsmedical7602@sedgwick.com, 1-800-913-3897; To report adverse events: globalcomplaints@icumed.com, 1-866-216-8806
• Quantity in Commerce: 142327 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.