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HeartSine Samaritan PAD SAM 350P (2014-06-12)
- Starting date:
- June 12, 2014
- Posting date:
- August 1, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40799
Recalled Products
HeartSine Samaritan PAD SAM 350P
Reason
An issue was detected with the seal on the foil pouch which contains the electrodes within the Pad-Pak/Pedi-Pak. On a small number the final seal of the defibrillation electrode pouch was difficult to open. After an investigation it was found that the supplier of the electrodes to HeartSine Technologies Ltd. made a change to the manufacturing process, which meant an excessive amount of hot melt glue was applied to the final seal of the pouches.
Affected products
HeartSine Samaritan PAD SAM 350P
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
SAM 350P
Companies
- Manufacturer
-
HeartSine Technologies, Ltd.
Canberra House, 203 Airport Road West,
Belfast, Northern Ireland
BT3 9ED
UNITED KINGDOM