Smiths Medical recalls reusable tracheal tube introducers (15Ch x 60cm) with specific model numbers and lot ranges 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 reusable tracheal tube introducers that could allow fluid to enter during reprocessing, potentially causing staining or inadequate disinfection. This risk affects medical devices used in hospitals for patient airways.
Fluid can enter the device at the rear between the end cap and tube during reprocessing. This may cause staining or allow fluid to remain, which could make standard disinfectants like hypochlorite solution (200ppm) and 4% acetic acid inadequate for proper cleaning.
Healthcare professionals using these tracheal tube introducers in hospitals or clinics. Patients receiving airway care with the recalled devices are at risk of potential staining or improper disinfection.
Check for model numbers REF 14-504-17 or REF 14-504-17JP. Look for specific lot numbers listed in the recall notice, including UDI/DI 35021239002579.
Identify if your device has model numbers REF 14-504-17 or REF 14-504-17JP.
Confirm if your device's lot numbers match the listed ranges in the recall notice.
Smiths Medical identified a potential for fluid ingress during reprocessing at the rear of the device between the end cap and tube, which could cause staining or allow fluid to remain, making standard disinfectants inadequate.
Check if your device matches the model numbers and lot numbers listed in the recall notice. If it does, contact Smiths Medical for further instructions.
The recall addresses potential staining or inadequate disinfection, not direct injury risks. The hazard is low risk as it does not involve immediate danger to users.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0527-2025 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0527-2025 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.
