Health product recall

Ventstar Breathing Circuits

Last updated

Summary

Product
Ventstar Breathing Circuits
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 catalog number
Ventstar Basic (N) 180 More than 10 numbers, contact manufacturer. MP00353
Seattle Pap Plus More than 10 numbers, contact manufacturer. MP02260
Ventstar Basic (P) 180 More than 10 numbers, contact manufacturer. MP00351
Ventstar Bag Set More than 10 numbers, contact manufacturer. MP00384-XX MP00383-XX
Ventstar Watertrap (P) 180 W/O Ll More than 10 numbers, contact manufacturer. MP00362
Ventstar Basic (P) 250 More than 10 numbers, contact manufacturer. MP00352
Ventstar Anesthesia Wt (P)180 More than 10 numbers, contact manufacturer. MP00374
Ventstar Coax (P) 150 More than 10 numbers, contact manufacturer. MP00379
Ventstar Anesthesia (N) 180 More than 10 numbers, contact manufacturer. MP00333

Issue

During global market surveillance activities, manufacturer became aware of cases in which glued connections of the breathing circuits  became loose either before or during the ventilation process resulting in partial or complete detachment of components such as watertrap, y-piece or hose connector. There were no reports of any adverse impact on the health of the patients involved. Investigations have identified that the adhesive joint did not conform to specification due to a manufacturing error. If system components become loose and/or detach from the hose during use, ventilation of the patient will be restricted.

Recall start date: March 22, 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 I
Identification number
RA-73450

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