CLASS II Device recall · Reported 30 Jul 2014 · FDA Enforcement Report
Pad-Pak and Pedi-Pak accessories recalled by Heartsine Technologies
Heartsine Technologies is recalling Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device, distributed nationwide in the US. The recall was initiated on 12 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2115-2014
- FDA event ID
- 68703
- Recalling firm
- Heartsine Technologies, Belfast
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2014
- FDA classified
- 24 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Pacemakers & Defibrillators
Timeline
| 12 Jun 2014 | Recall initiated by company | |
| 24 Jul 2014 | Classified by FDA | +42 days |
| 30 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
Questions about this recall
Why was it recalled?
A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy.
Which lots are affected?
Pad-Pak 01 & Pad-Pak 02 ¿ Adult Lot Numbers: A1785 to A1805 ¿ Pediatric Lot Numbers: P433 to P445.
Where was it sold?
Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Heartsine Technologies
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HeartSine Pad-Pak recalled by HeartSine Technologies | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine samaritan PAD (Public Access Defibrillator), Type recalled | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine samaritan PAD (Public Access Defibrillator): Type recalled | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine, REF: Pad-pak-01, Pad-pak-03 AND Pad-pak-03j, CE0123 sold recalled | HeartSine Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | Heartsine Samaritan PAD: SAM 350P semi-automatic recalled | HeartSine Technologies | Other | 8 states |
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