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No image published for this recall

Ambu vivasight 2 dlt kit

Official notice

20 Jun 2022

Last checked

20 Jun 2022

Critical riskHealth Canada

An official Health Canada notice concerns Ambu vivasight 2 dlt kit. 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 Published 2022-06-20.

What to do now

Confirm receipt of the field safety notice and destroy any remaining units in inventory.

Recall number

64290

Official notice

2022-06-20

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64290

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Affected products

Product 1

Affected products - Ambu Vivasight 2 Dlt Kit, Lot or serial number - All lots., Model or catalogue number - 412391000 412351000 412411000 412371000

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Ambu A S, Ambu Vivasight 2 Dlt Kit.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

64290

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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