smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Published December 4, 2024 · Recall initiated: October 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- Worldwide distribution.
- Lot
- REF 14-504-68, UDI/DI 35021239002586, Lot Numbers: 0003393, 0003394, 0003357, 0003358, 0003267, 0003368, 0003634, 0003254, 0003369, 0003165, 0003184, 0003196, 0003204, 0003206, 0003226, 0003256, 0003300, 0003307, 0003308, 0003314, 0003322, 0003359, 0003360, 0003361, 0003362, 0003363, 0003364, 0003377, 0003380, 0003635, 0003643; REF 14-504-68JP, UDI/DI 35021239002586, Lot Numbers: 0003369, 0003377, 0003393, 0003394, 0003634, 0003635, 0003643
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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