Z-2115-2014 Class II Terminated
FDA device recall Z-2115-2014 was initiated by Heartsine Technologies, Limited on June 12, 2014 and is designated Class II. 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. The recall status is terminated (terminated April 16, 2015). Affected quantity: 3245.
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.