Health product recall

Anesthesia Set Flex, Latex Free, Us

Last updated

Summary

Product
Anesthesia Set Flex, Latex Free, Us
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

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

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Draegerwerk Ag & Co. Kgaa

Moislinger Allee 53-55, Lubeck, Germany, 23542

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72663

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