Smiths Medical recalls PORTEX Tracheal Tube Exchange Guides (15Ch x 70cm) with specific model numbers and lot codes due to potential fluid ingress during reprocessing, which may cause staining or inadequate disinfection.
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 certain PORTEX Tracheal Tube Exchange Guides because fluid can enter the device during reprocessing, potentially causing staining or allowing disinfectants to be ineffective. This could lead to improper sterilization of the device.
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 make the recommended disinfectants (hypochlorite solution and acetic acid) inadequate for proper sterilization.
Healthcare professionals using the recalled tracheal tube exchange guides for medical procedures are most at risk. Patients using these devices could be affected if the guides are not properly disinfected.
Check for model numbers REF 14-504-68 or REF 14-504-68JP with specific lot numbers listed in the recall notice. The device is a 15Ch x 70cm tracheal tube exchange guide.
Identify the model number (REF 14-504-68 or REF 14-504-68JP) and lot numbers from the list provided in the recall notice.
Smiths Medical identified a potential for fluid to enter the device during reprocessing, which could cause staining or allow disinfectants to be ineffective.
Fluid ingress during reprocessing may lead to staining or inadequate disinfection, potentially affecting the device's sterility.
Check for model numbers REF 14-504-68 or REF 14-504-68JP with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0528-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0528-2025 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.
