Home / Recalls / Heartsine Technologies, Limited / Z-2115-2014

Z-2115-2014 Class II Terminated

Recalled by Heartsine Technologies, Limited — Belfast

Recall Details

Product Type: Devices
Report Date: July 30, 2014
Initiation Date: June 12, 2014
Termination Date: April 16, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3245

Product Description

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.

Reason for Recall

A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.

Distribution Pattern

Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.

Code Information

Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.