Smiths Medical ASD, Inc.: Device Recall

Recall Details

Recall Number

Z-0185-2025

Classification

Class II

Product Type

Device

Recalling Firm

Smiths Medical ASD, Inc.

Status

Ongoing

Date Initiated

09/24/2024

Location

Minneapolis, MN, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

400 units

Reason for Recall

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

Product Description

medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1

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. →