Smiths Medical ASD Inc.: Device Recall

Recall #Z-2601-2024 · 05/29/2024

Class I: Dangerous

Recall Details

Recall Number: Z-2601-2024
Classification: Class I
Product Type: Device
Recalling Firm: Smiths Medical ASD Inc.
Status: Ongoing
Date Initiated: 05/29/2024
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

Product Description

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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.