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