Anesthesia Set Flex, Latex Free, Us
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Draegerwerk Ag & Co. Kgaa
Moislinger Allee 53-55, Lubeck, Germany, 23542
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