Recall Z-0528-2025— Smiths Medical ASD, Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2024-10-28. FDA's recall record names no specific 510(k) clearance for this event. Product: smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP. Reason: 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..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-28
- Firm location
- Minneapolis, MN, United States
Product description
smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.