DRAEGERWERK AG & CO. KGAA's Disposable Breathing Circuits (2018-12-23)
- 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
Affected products
- VentStar Watertrap 180
- VentStar Watertrap 180 W/O Luerlock
- VentStar Basic 180
- VentStar Basic 250
- VentStar Basic (P)180
- VentStar Watertrap (Pediatric) 180 W/O Luerlock
- VentStar Basic(P)250
- VentStar Anesthesia Watertrap 180 W/O Luerlock
- VentStar Anesthesia Watertrap 180
- VentStar Anesthesia Watertrap (P) 180
- VentStar Anesthesia Basic 180
- VentStar Anesthesia Basic 250
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.
Affected products
A. VentStar Watertrap 180
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00337
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
B. VentStar Watertrap 180 W/O Luerlock
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00334
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
C. VentStar Basic 180
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00349
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
D. VentStar Basic 250
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00350
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
E. VentStar Basic (P)180
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00351
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
F. VentStar Watertrap (Pediatric) 180 W/O Luerlock
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00362
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
G. VentStar Basic(P)250
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00352
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
H. VentStar Anesthesia Watertrap 180 W/O Luerlock
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00371
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
I. VentStar Anesthesia Watertrap 180
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00372
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
J. VentStar Anesthesia Watertrap (P) 180
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00374
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
K. VentStar Anesthesia Basic 180
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00365
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY
L. VentStar Anesthesia Basic 250
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
MP00366
Companies
- Manufacturer
-
DRAEGERWERK AG & CO. KGAA
MOISLINGER ALLEE 53-55
LUBECK
23542
GERMANY