Smiths Medical ASD Inc.: Device Recall

Recall Details

Recall Number

Z-2603-2024

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) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040

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. →