FDA Device recall 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…
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator… by Heartsine Technologies, citing A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2115-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-12 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heartsine Technologies |
| Distribution | US |
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.
Identifiers
| code_info | Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2115-2014%22
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