DRAEGERWERK AG & CO. KGAA Recalls Disposable Breathing Circuits -- Canada Recalls

Reason

Two cases have been reported in which patients were not connected to the anesthesia machine due to the incorrect connection of the breathing circuit. The connections of the anesthesia machine and of the Y piece were short- circuited. Consequently, the patients did not receive the expected ventilation; in one of the two cases the patient in question suffered irreversible harm, in the other case the patient experienced a temporary and reversible deterioration in condition.

Starting date:

December 23, 2018

Posting date:

December 27, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68712

• Reason
• Affected products

Affected products

1. VentStar Watertrap 180
2. VentStar Watertrap 180 W/O Luerlock 
3. VentStar Basic 180
4. VentStar Basic 250
5. VentStar Basic (P)180
6. VentStar Watertrap (Pediatric) 180 W/O Luerlock 
7. VentStar Basic(P)250
8. VentStar Anesthesia Watertrap 180 W/O Luerlock 
9. VentStar Anesthesia Watertrap 180
10. VentStar Anesthesia Watertrap (P) 180
11. VentStar Anesthesia Basic 180
12. VentStar Anesthesia Basic 250

Manufacturer

DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY