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Health product recall

VentStar Helix heated, dual heated (2019-03-27)

Starting date:
March 27, 2019
Posting date:
April 9, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-69542

Last updated: 2019-04-09

Affected Products

A. VentStar Helix dual heated
B. VentStar Helix heated

Reason

Several cases have come to Draeger's attention in which cracks have formed in the breathing hose during ventilation.  If a crack forms in the breathing hose during operation, a leak will result that can negatively affect ventilation of the patient. If the breathing circuit is used with devices listed as compatible in the Instructions for Use, any leakages will be detected and the device will give an alarm.

Affected products

A. VentStar Helix dual heated

Lot or serial number

115953
118230
119562
121061
122656
123256
124964
124965
125405
134742

Model or catalog number

MP02606

Companies
Manufacturer

Draegerwerk AG & Co. KGaA

Moislinger Allee 53-55

Lübeck

23542

GERMANY

B. VentStar Helix heated

Lot or serial number

115878
118059

Model or catalog number

MP02607

Companies
Manufacturer

Draegerwerk AG & Co. KGaA

Moislinger Allee 53-55

Lübeck

23542

GERMANY