smiths medical PORTEX Tracheal Tube Exchange Guide recall
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
Why was smiths medical PORTEX Tracheal Tube Exchange Guide 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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,
- Product
- smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 12282 units
- Distribution
- Worldwide distribution.
- Recall date
- December 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)