Smiths Medical recalls PORTEX Tracheal Tube Exchange Guides (10Ch x 70cm) due to potential fluid ingress during reprocessing, which may cause staining or inadequate disinfection. Affected units have specific lot numbers.
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.
Smiths Medical is recalling tracheal tube exchange guides that could allow fluid to enter during reprocessing, potentially causing staining or inadequate disinfection. This risk affects healthcare facilities using these devices for patient care.
Fluid can enter the device during reprocessing at the rear between the end cap and tube. This may cause staining or allow fluid to remain inside, which could lead to inadequate disinfection with recommended solutions.
Healthcare facilities using the recalled tracheal tube exchange guides for patient care are most at risk. The specific lot numbers listed in the recall affect medical devices used in hospitals and clinics.
Check for the product name 'Smiths medical PORTEX Tracheal Tube Exchange Guide', size 10Ch x 70cm, and lot numbers listed in the recall (e.g., 0003373, 0003456).
Identify the lot number on the device or packaging to confirm if it's affected by this recall.
Smiths Medical identified a potential for fluid to enter the device during reprocessing, which could cause staining or inadequate disinfection with recommended solutions.
Check the lot number on the device or packaging to see if it's in the list of affected units. If it is, contact Smiths Medical for further instructions.
The recall addresses potential staining or inadequate disinfection during reprocessing, but does not indicate immediate safety risks to users during normal medical use.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0529-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0529-2025 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
