Smiths Medical ASD, Inc.: Device Recall

Recall #Z-0528-2025 · 10/28/2024

Class II: Risk

Recall Details

Recall Number: Z-0528-2025
Classification: Class II
Product Type: Device
Recalling Firm: Smiths Medical ASD, Inc.
Status: Ongoing
Date Initiated: 10/28/2024
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,223 units

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.

Product Description

smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP

Distribution Pattern

Worldwide distribution.

Other Recalls by Smiths Medical ASD, Inc.

Class I: Dangerous 04/10/2025

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Class I: Dangerous 04/10/2025

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Class I: Dangerous 04/10/2025

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Class I: Dangerous 04/10/2025

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Class I: Dangerous 04/10/2025

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

View all recalls by Smiths Medical ASD, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.