Smiths Medical Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk
Smiths Medical recalled its PORTEX Tracheal Tube Exchange Guide due to potential fluid ingress during reprocessing that may compromise disinfection standards and pose a contamination risk.
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 an FDA Class II medical device recall with no reported illnesses or injuries. The hazard involves potential contamination through inadequate disinfection of a critical respiratory device, fitting the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. has recalled its PORTEX Tracheal Tube Exchange Guide (models REF 14-504-68 and REF 14-504-68JP), a medical device used in respiratory care to assist in the safe replacement of endotracheal tubes.
The recall was initiated because fluid can potentially enter the device during reprocessing between the end cap and tube. This fluid ingress can cause staining or allow fluid to remain inside the device. Additionally, the disinfectants recommended in the device's instructions—Hypochlorite Solution (200ppm) and 4% Acetic Acid—may not meet the required disinfection standards for this type of device, potentially leaving harmful microorganisms present.
The recall affects approximately 10,223 units distributed worldwide across 31 affected lot numbers. Healthcare facilities using affected devices should discontinue use and contact Smiths Medical for replacement or return instructions.
The recalled product
- Product
- smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- fluid-ingress
- inadequate-disinfection
- contamination-risk
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 14-504-68
- UDI/DI 35021239002586
- Lot Numbers: 0003393
- 0003394
- 0003357
- 0003358
- 0003267
- 0003368
- 0003634
- 0003254
- 0003369
- 0003165
- 0003184
- 0003196
- 0003204
- 0003206
- 0003226
- 0003256
- 0003300
- 0003307
Distribution
Distribution scope not specified by the agency.
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