FDA Device recall Z-0527-2025

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

FDA Device
Class II
ongoing
Published 2024-12-04

On 2024-12-04 the FDA classified a Class II recall of smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP by Smiths Medical Asd, citing 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 t….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0527-2025
Classification	Class II
Status	ongoing
Initiated	2024-10-28
Published	2024-12-04
Last updated	2026-09-13 11:57 UTC
Company	Smiths Medical Asd
Distribution	n/a

Product

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

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.

Identifiers

code_info	REF 14-504-17, UDI/DI 35021239002579, Lot Numbers: 0003340, 0003620, 0003616, 0003580, 0003542, 0003509, 0003579, 0003… 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, 000

code_info

REF 14-504-17, UDI/DI 35021239002579, Lot Numbers: 0003340, 0003620, 0003616, 0003580, 0003542, 0003509, 0003579, 0003…

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, 000

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0527-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.