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Anesthesia set flex, latex free, us

Official notice

8 Feb 2023

Last checked

8 Feb 2023

Medium riskHealth Canada
Watch Draegerwerk Kgaa

An official Health Canada notice concerns Anesthesia set flex, latex free, us. In the course of internal quality controls, Draeger has noticed that some of their flex ventilation hoses have contaminations. Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses. Draeger's analyses have shown that particles are not reliably detected by visual inspection prior to use. So far, they have not received any customer feedback on the mentioned contamination. However, they cannot rule out the possibility that they have shipped affected hoses. If the contaminated flex ventilation hoses are used without filters on the patient side, it cannot be ruled out that particles enter the airway of the affected patients and cause coughing, irritation or toxicological effects. Recall start date: January 24, 2023 Published 2023-02-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72663

Official notice

2023-02-08

The hazard

In the course of internal quality controls, Draeger has noticed that some of their flex ventilation hoses have contaminations. Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses. Draeger's analyses have shown that particles are not reliably detected by visual inspection prior to use. So far, they have not received any customer feedback on the mentioned contamination. However, they cannot rule out the possibility that they have shipped affected hoses. If the contaminated flex ventilation hoses are used without filters on the patient side, it cannot be ruled out that particles enter the airway of the affected patients and cause coughing, irritation or toxicological effects. Recall start date: January 24, 2023

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

72663

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Affected products

Product 1

Affected products - Anesthesia Set Flex, Latex Free, Us, Lot or serial number - All lots., Model or catalogue number - MP00303-XX

Risk / hazard

In the course of internal quality controls, Draeger has noticed that some of their flex ventilation hoses have contaminations. Due to a deviation in the manufacturing process, components of the hose material remained as particles inside the hoses. Draeger's analyses have shown that particles are not reliably detected by visual inspection prior to use. So far, they have not received any customer feedback on the mentioned contamination. However, they cannot rule out the possibility that they have shipped affected hoses. If the contaminated flex ventilation hoses are used without filters on the patient side, it cannot be ruled out that particles enter the airway of the affected patients and cause coughing, irritation or toxicological effects. Recall start date: January 24, 2023

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Draegerwerk Kgaa, Anesthesia Set Flex Latex Free

Manufacturer

Not provided

Phone

Not provided

Brand: Draegerwerk Kgaa, Anesthesia Set Flex Latex Free.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72663

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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