FDA-Device2024-12-04Class II
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical ASD, Inc.
Hazard
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.
Sold states
Worldwide distribution.
Affected count
10,223 units
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0528-2025Don't want to check this manually?
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