Smiths Medical Tracheal Tube Introducer Recall Due to Inadequate Disinfection
Smiths Medical is recalling reusable tracheal tube introducers due to potential fluid ingress during reprocessing and concerns about the adequacy of recommended disinfectants.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with potential for inadequate disinfection and fluid retention, but no illnesses or injuries have been reported. FDA Class II classification without reported harm warrants a High severity rating per the rubric.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the Portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm (REF 14-504-17 and REF 14-504-17JP). Approximately 142,327 units have been distributed worldwide.
Smithis Medical identified a potential safety defect: fluid can enter the device during reprocessing at the seam between the end cap and the tube. This fluid ingress could cause staining or allow fluid to remain inside the device. Additionally, the disinfectants recommended in the instructions—Hypochlorite Solution (200 ppm) and 4% Acetic Acid—may not provide adequate disinfection according to standards applicable to reusable devices of this type.
The recall affects healthcare facilities and providers using these introducers during airway management procedures. Users should verify whether their inventory includes the affected lot numbers and contact Smiths Medical for guidance on device replacement or return.
The recalled product
- Product
- smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 142,327
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF 14-504-17
- UDI/DI 35021239002579
- Lot Numbers: 0003340
- 0003620
- 0003616
- 0003580
- 0003542
- 0003509
- 0003579
- 0003568
- 0003599
- 0003615
- 0003589
- 0003562
- 0003601
- 0003618
- 0003583
- 0003613
- 0003270
- 0003629
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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