Home / Recalls / Medical Devices
Heartsine Technologies, Limited recalls Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated
Recalled July 30, 2014 · FDA recall Z-2115-2014 · Heartsine Technologies
Hazard
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. · FDA Class II
Units
3245
Sold at
Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
Description
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
Product
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.
Manufacturer(s)
Heartsine Technologies, Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →