Reported Nov 6, 2024 · Ongoing
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr…
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. · 6721 Columbia Gateway Dr Ste 200 · Columbia, MD · 21046-3380
Is this the product you have?
Ambu¿ VivaSight 2 DLT Endobronchial tube35 FR (Catalog Number 412351000)37 Fr (Catalog Number 412371000)39 Fr (Catalog Number 412391000)41 Fr (Catalog Number 412411000)
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 VivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855 2 VivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861 3 VivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917 4 VivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434 - Amount recalled
- 1824
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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