Reported Jul 27, 2022 · Ongoing
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers…
Ambu Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ambu Inc. · 6230 Old Dobbin Ln Ste 250 · Columbia, MD · 21045-5955
Is this the product you have?
- Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
- Lot codes and dates
- Catalog No412351000
- UDI-DI5707480145706 1 each 5707480145713 5 pc/pack Catalog No. 412371000
- UDI-DI5707480145737 1 each 5707480145744 5 pc/pack Catalog No. 412391000
- UDI-DI5707480145768 1 each 5707480145775 5 pc/pack Catalog No. 412411000
- UDI-DI5707480145799 1 each 5707480145805 5 pc/pack All lots
- Amount recalled
- 12,921
Where it was sold
- Nationwide
Why it was recalled
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
This product could cause temporary or reversible health problems — stop using it.
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