Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Reported: July 27, 2022 Initiated: June 3, 2022 #Z-1420-2022
Product Description
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Reason for Recall
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.
Details
- Recalling Firm
- Ambu Inc.
- Units Affected
- 12,921
- Distribution
- Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK Canada, Australia, New Zealand, Israel .
- Location
- Columbia, MD
Frequently Asked Questions
What product was recalled? ▼
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000. Recalled by Ambu Inc.. Units affected: 12,921.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1420-2022.
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