Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)

Recall fda-alert:2024-09-04:Bivona:Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s) · Published 2024-09-04

Official-information notice / 官方信息说明: This page transcribes fields from the named agency record. It is not medical, legal, or food-safety advice. Follow the agency's original notice and instructions.

Recall number / 召回编号

fda-alert:2024-09-04:Bivona:Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)

Classification / 风险等级

Other / 其他

Published / 发布时间

2024-09-04

Recalling firm / 召回企业

Smiths Medical

Product description / 产品描述

Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)

Product code / 产品代码

Not provided in the official record

Code information / 批次与代码信息

Not provided in the official record

Product quantity / 产品数量

Not provided in the official record

Distribution / 销售地区

Not provided in the official record

Reason for recall / 召回原因

The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

Open official source ↗ / 打开官方来源

Last synchronized: 2024-09-04. Recall Radar does not replace agency guidance.