Ambu Vivasight 2 Dlt Kit
Brand(s)
Last updated
Summary
Product
Ambu Vivasight 2 Dlt Kit
Issue
Medical devices - Performance issue
What to do
Confirm receipt of the field safety notice and destroy any remaining units in inventory.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Ambu Vivasight 2 Dlt Kit |
All lots. |
412391000 |
Issue
|
Ambu has received complaints on Vivasight 2 Dlt concerning leak/rupture of either the bronchial or tracheal cuff. Leakage occurred during procedure could potentially lead to loss of secure airway and will require re-intubation of the patient. Recall start date: June 7, 2022 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Ambu A/S
Baltorpbakken 13, Ballerup, Denmark, 2750
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64290
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