Drug recall
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P)…
FDA recall event 68703 · Class II · Heartsine Technologies, Limited
Key facts
| Event ID | 68703 |
|---|---|
| Recall numbers | Z-2115-2014 |
| Recalling firm | Heartsine Technologies, Limited |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jun 12, 2014 |
| Report date | Jul 30, 2014 |
| Termination date | Apr 16, 2015 |
| City | Belfast |
| Country | United Kingdom |
| FEI number | 3004123209 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: