Smiths Medical ASD Inc.: Device Recall

Recall #Z-0018-2025 · 06/26/2024

Class II: Risk

Recall Details

Recall Number: Z-0018-2025
Classification: Class II
Product Type: Device
Recalling Firm: Smiths Medical ASD Inc.
Status: Ongoing
Date Initiated: 06/26/2024
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 120960 units

Reason for Recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Product Description

ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28

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.