Public recall detail

Anesthesia Set Flex, Latex Free, Us

2023-02-08

medium
Recall Safety notice
Quick summary

Quick summary: Anesthesia Set Flex, Latex Free, Us. Date: 2023-02-08.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Anesthesia Set Flex, Latex Free, Us. Date: 2023-02-08.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandDraegerwerk Ag & Co. Kgaa
ProductAnesthesia Set Flex, Latex Free, Us
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72663

Affected products

ProductAnesthesia Set Flex, Latex Free, Us
LotAll lots.
ModelMP00303-XX
Serial numberAll lots.
DescriptionAnesthesia Set Flex, Latex Free, Us

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesDraegerwerk Ag & Co. Kgaa Moislinger Allee 53-55, Lubeck, Germany, 23542
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72663
Background{}
CompaniesDraegerwerk Ag & Co. Kgaa Moislinger Allee 53-55, Lubeck, Germany, 23542
AudiencesHealthcare
Source updated2023-02-08

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...