Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk
Smiths Medical is recalling PORTEX Tracheal Tube Exchange Guides due to potential fluid ingress during reprocessing and inadequate disinfection per applicable standards.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is potential—inadequate disinfection and fluid ingress during reprocessing pose a risk of harm in a critical medical device used for airway management procedures.
Plain-English summary
Smiths Medical is recalling the PORTEX Tracheal Tube Exchange Guide (10Ch x 70cm, REF 14-504-76), a medical device used in tracheal intubation procedures. The recall affects 12,282 units with worldwide distribution.
The manufacturer identified a potential for fluid ingress into the device during reprocessing. Specifically, fluid can enter at the rear of the device between the end cap and the tube. This could lead to staining of the device or allow residual fluid to remain inside. Additionally, the disinfectants recommended in the device's instructions for use—Hypochlorite Solution at 200ppm concentration and 4% Acetic Acid—may not adequately disinfect the device according to applicable disinfection standards for this device type.
Affected healthcare facilities should stop using products from the recalled lot numbers and contact Smiths Medical for replacement instructions. The complete list of affected lot numbers is available in the official FDA recall notice.
The recalled product
- Product
- smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- fluid-ingress
- inadequate-disinfection
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)
- UDI/DI 35021239002593
- Lot Numbers: 0003373
- 0003456
- 0003621
- 0003374
- 0003376
- 0003375
- 0003459
- 0003391
- 0003480
- 0003549
- 0003301
- 0003124
- 0003130
- 0003139
- 0003140
- 0003144
- 0003148
- 0003152
- 0003161
Distribution
Distribution scope not specified by the agency.
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