Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P… — Class II medical device recall Z-2115-2014
Terminated recall by Heartsine Technologies, Limited, reported 2014-07-30, distributed nationwide. A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting
| Recall number | Z-2115-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartsine Technologies, Limited, Belfast, United Kingdom |
| Recall initiated | 2014-06-12 |
| Classified | 2014-07-24 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2015-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 3,245 |
| Lot numbers | A1785, A1805, P433, P445 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2115-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.