Recall Z-2115-2014— Heartsine Technologies, Limited
Class II · Terminated
Class II FDA medical device recall by Heartsine Technologies, Limited, initiated 2014-06-12, terminated 2015-04-16. It names 2 FDA 510(k) clearances: K123881, K052465. 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.. Reason: A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy..
- Recalling firm
- Heartsine Technologies, Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-12
- Terminated
- 2015-04-16
- Firm location
- Belfast, United Kingdom
510(k) clearances named in this recall
2 on FDA's record- K123881 — HEARTSINE SAMARITAN PAD 350P
- K052465 — REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.