Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.
INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODE (2017-11-17)
- Starting date:
- November 17, 2017
- Posting date:
- November 22, 2017
- 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-65174
Affected products
INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODE
Reason
The artwork on the defibrillation electrodes does not meet physio-control's specifications, and shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes, this is limited to incorrect artwork on the defibrillation electrodes within the packaging. The artwork on the electrode packaging shows the correct electrode placement for an infant.
Affected products
INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODE
Lot or serial number
45932237
45979590
46061770
713609
713904
715008
717912
718033
Model or catalog number
3202380-006
3202784-009
Companies
- Manufacturer
-
Physio-Control Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES
- Date modified: