FDA Medical devices recall ·
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm recall
- Recall number
- Z-0529-2025
- Date
- (initiated October 28, 2024)
- Company / brand
- Smiths Medical ASD, Inc.
6000 Nathan Ln N, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12282 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 35021239002593, Lot Numbers: 0003373, 0003456, 0003621, 0003374, 0003376, 0003375, 0003459, 0003391, 0003480, 0003549, 0003301, 0003124, 0003130, 0003139, 0003140, 0003144, 0003148, 0003152, 0003161, 0003169, 0003185, 0003205, 0003210, 0003222, 0003232, 0003236, 0003255, 0003276, 0003277, 0003315, 0003329, 0003339, 0003367, 0003370, 0003371, 0003372, 0003381, 0003395, 0003399, 0003403, 0003414, 0003449, 0003457, 0003469, 0003476, 0003477, 0003489, 0003492, 0003500, 0003573, 0003484, 0003619, 0003557, 0003510, 0003522, 0003597, 0003511, 0003622, 0003553, 0003581, 0003605, 0003529,
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0529-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.