LAPRAOSCOPIE and ENDOCHOLECYSTECTOMIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves (2018-07-04)
- Starting date:
- July 4, 2018
- Posting date:
- July 13, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67230
Affected products
A. LAPRAOSCOPIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves
B. ENDOCHOLECYSTECTOMIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves
Reason
Cardinal Health has become aware of an issue in which the Hydroline and Pulse Wave Trumpet Valves (components ASU1200 and ASU1201, Probe 5mm x 33cm DISP Fixed) may not close properly which could cause continuous suction. There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue. Cardinal Health is not aware of any reports of injury attributed to this issue.
Affected products
A. LAPRAOSCOPIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves
Lot or serial number
788534
832528
Model or catalog number
SLC30LAJTA
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES
B. ENDOCHOLECYSTECTOMIE Presource Kits Containing Hydroline and Pulse Wave Trumpet Valves
Lot or serial number
795674
804705
Model or catalog number
SLC30ECBEB
Companies
- Manufacturer
-
Cardinal Health
3651 Birchwood Drive
Waukegan
60085
Illinois
UNITED STATES