Product Wiki · Recalls · Health Canada — Medical Devices

HeartSine Samaritan PAD SAM 350P (2014-06-12) — recall 51687

Health Canada — Medical Devices · Canada · 2014-08-01 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51687
Date of alert
2014-08-01
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartsine-samaritan-pad-sam-35

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