Infant/Child Reduced Energy Defibrillation Electrode (2020-05-04)
- Starting date:
- May 4, 2020
- Posting date:
- May 22, 2020
- 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-73161
Last updated: 2020-05-22
Affected Products
Infant/Child Reduced Energy Defibrillation Electrode
Reason
Through the product complaint program, Stryker has become aware that certain packages of infant child reduced energy electrodes produced by Cardinal Health, Inc. May have compromised seals. The compromised packaging seal has the potential to result in the electrodes becoming dried out. This could result in inadequate adhesion to patient, failure of the defibrillator to detect patient connection, ineffective or no energy delivered to patient, or patient burns. There have been no patient related occurrences with this issue.
Affected products
Infant/Child Reduced Energy Defibrillation Electrode
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
11101-000016
Companies
- Manufacturer
-
Physio-Control, Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES