Heartsine Technologies, Limited: Medical Device Recall in 2014 - (Recall #: Z-2115-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 12, 2014

Date Posted: July 30, 2014

Recall Number: Z-2115-2014

Event ID: 68703

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.

Status: Terminated

Product Quantity: 3245

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated