Recall Z-1420-2022— Ambu Inc.
Class II · Ongoing
Class II FDA medical device recall by Ambu Inc., initiated 2022-06-03. It names one FDA 510(k) clearance: K203749. Product: Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000. Reason: 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..
- Recalling firm
- Ambu Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-03
- Firm location
- Columbia, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.