ICU Medical Recalls Certain Tracheostomy Tubes Due To Manufacturing Defects
ICU Medical Recalls Certain Tracheostomy Tubes Due To Manufacturing Defects
Affected products include:On Wednesday, ICU Medical Inc's (NASDAQ:ICUI) subsidiary, Smiths Medical, initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes.
周三，ICU Medical Inc.（NASDAQ：ICUI）的子公司Smiths Medical启动了对特定Bivona新生儿/儿童和成人气管造口管的召回。
The FDA classified the recall as the most serious type, which could cause severe injury or death.
FDA将该召回分类为最严重类型，可能导致严重的伤害或死亡。
Smiths Medical is recalling specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect that may cause the securement flange of the device to tear.
Smiths Medical正在召回特定批次的Bivona新生儿/儿童和成人气管造口管，因制造缺陷可能导致设备的固定翼撕裂。
Affected products include:
受影响的产品包括：
- Bivona Aire-Cuf, TTS, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tubes.
- Bivona Aire-Cuf, TTS, Cuffless FlexTend, TTS FlexTend Adult Tracheostomy Tubes.
- Bivona Aire-Cuf、TTS、无袖中间区域新生儿/儿童气管造口管。
- Bivona Aire-Cuf、TTS、无袖FlexTend、TTS FlexTend成人气管造口管。
The use of affected products may cause serious adverse health consequences, including lack of proper ventilation, loss of a protected airway, and death.
使用受影响的产品可能导致严重的不良健康后果，包括缺乏适当通气、失去受保护的气道和死亡。
There have been 35 reported injuries. There have been two reports of death.
已报告35起受伤事件。已报告2起死亡事件。
Bivona neonatal/pediatric and adult tracheostomy tubes provide direct airway access for up to 29 days for a patient with a tracheostomy, a surgical procedure that creates an opening in the neck and into the windpipe (trachea) to help a person breathe.
Bivona新生儿/儿科和成人气管切开管为经气管造口手术的患者提供直接气道通路，最长可持续29天，该手术在颈部和气管（气管）上切开一个孔以帮助人们呼吸。
Some tubes can be reprocessed and reused several times for a single patient.
一些管子可以重新处理和多次重复使用给同一个患者。
The company said not to use the Bivona tracheostomy tubes from the affected lot numbers. They should be thrown away.
该公司表示不要使用受影响批号的Bivona气管切开管。请将其丢弃。
Price Action: At last check Thursday, ICUI stock was up 2.25% at $180.19.
价格行动：截至上周四的最后一次询价，ICUI股票上涨了2.25%，至180.19美元。
- Zimmer Biomet To Stop Selling CPT Hip Implant System By End Of 2024 Due To High Fracture Risks.
- 由于高碎裂风险，Zimmer Biomet将在2024年底停止销售CPt人工髋关节植入系统。