Smiths Medical ASD, Inc.: Device Recall

Recall #Z-1283-2025 · 02/13/2025

Class I: Dangerous

Recall Details

Recall Number: Z-1283-2025
Classification: Class I
Product Type: Device
Recalling Firm: Smiths Medical ASD, Inc.
Status: Ongoing
Date Initiated: 02/13/2025
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1961 units

Reason for Recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Product Description

smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

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.