FDA-Device2014-07-30Class II
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
Heartsine Technologies, Limited
Hazard
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
Sold states
Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
Affected count
3245
Manufactured in
203 Airport Road West, Belfast, United Kingdom
Products
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2014Don't want to check this manually?
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