FDAFDA · Food and drugs·Recall number Z-2115-2014
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.
Published July 30, 2014 · Recall initiated: June 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Heartsine Technologies, Limited
- Distributor
- Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
- Lot
- Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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