FDA Enforcement
Class II
Ongoing
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
Recall: Z-0261-2025
·
Reported November 6, 2024
Enforcement
- Recall Number
- Z-0261-2025
- Event ID
- 95454
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ambu Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 6, 2024
- Initiation Date
- September 16, 2024
- Classification Date
- October 30, 2024
- Address
- 6721 Columbia Gateway Dr Ste 200, N/A, Columbia, MD, 21046-3380, United States
Description
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
Reason
Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.
Code Info
Lot Codes: VivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855; VivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861; VivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917; VivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434
Distribution
US Nationwide. Canada.
Quantity
1824