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

Recall date

October 28, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0527-2025

FDA classification

Class II

Brand / firm

Smiths Medical ASD, Inc.

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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