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.
週三，ICU Medical Inc.（NASDA****）的子公司Smiths Medical啓動了對特定Bivona新生兒/兒童和成人氣管造口管的召回。
The FDA classified the recall as the most serious type, which could cause severe injury or death.
FDA將該召回分類爲最嚴重類型，可能導致嚴重的傷害或死亡。
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新生兒/兒童和成人氣管造口管，因製造缺陷可能導致設備的固定翼撕裂。
Affected products include:
受影響的產品包括：
- 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、無袖中間區域新生兒/兒童氣管造口管。
- Bivona Aire-Cuf、TTS、無袖FlexTend、TTS FlexTend成人氣管造口管。
The use of affected products may cause serious adverse health consequences, including lack of proper ventilation, loss of a protected airway, and death.
使用受影響的產品可能導致嚴重的不良健康後果，包括缺乏適當通氣、失去受保護的氣道和死亡。
There have been 35 reported injuries. There have been two reports of death.
已報告35起受傷事件。已報告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新生兒/兒科和成人氣管切開管爲經氣管造口手術的患者提供直接氣道通路，最長可持續29天，該手術在頸部和氣管（氣管）上切開一個孔以幫助人們呼吸。
Some tubes can be reprocessed and reused several times for a single patient.
一些管子可以重新處理和多次重複使用給同一個患者。
The company said not to use the Bivona tracheostomy tubes from the affected lot numbers. They should be thrown away.
該公司表示不要使用受影響批號的Bivona氣管切開管。請將其丟棄。
Price Action: At last check Thursday, ICUI stock was up 2.25% at $180.19.
價格行動：截至上週四的最後一次詢價，ICUI股票上漲了2.25%，至180.19美元。
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譯文內容由第三人軟體翻譯。