FDA (Devices) recall action 95605
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Smiths Medical recalled its PORTEX Tracheal Tube Exchange Guide due to potential fluid ingress during reprocessing that may compromise disinfection standards and pose a contamination risk.
Smiths Medical is recalling PORTEX Tracheal Tube Exchange Guides due to potential fluid ingress during reprocessing and inadequate disinfection per applicable standards.
Smiths Medical is recalling reusable tracheal tube introducers due to potential fluid ingress during reprocessing and concerns about the adequacy of recommended disinfectants.