Health product recall

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

  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

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