Smiths Medical ASD, Inc.: smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

Recall number

Z-0527-2025

Recalling firm

Smiths Medical ASD, Inc.

Product

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

Status

Open, Classified

Initiated

2024-10-28

Posted

2024-11-25

Terminated

not on file

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.

Root 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

142327 units

Distribution

Worldwide distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

BSR

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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