FDA-Device2026-09-23Class IIPROCESSING DEFECT
SunMed Tracheal Tube Size 2.5 recalled for suction catheter obstruction risk
What this means
The 6Fr suction catheter may not pass smoothly through certain SunMed Tracheal Tube Size 2.5 samples (Model 1-7333-25), creating a potential obstruction during use. This issue affects multiple lot numbers distributed nationwide.
- Stop using affected tracheal tubes (check lot number against the recall list).
- Contact your healthcare facility or medical supplier for replacement or guidance.
- If you have questions, contact WELL LEAD MEDICAL CO. LTD with your lot number and UDI-DI 10889483048108.
The agency's original wording
Hazard
The 6Fr suction catheter could not pass through the samples smoothly.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of MI.
Affected count
27200
Manufactured in
NO. 47 Guomao Avenue South , Panyu, N/A, Guangzhou, N/A, China
Products
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3172-2026Want us to check the next one for you?
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