Device recall
Z-2115-2014: Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P…
FDA device recall · Class II · Heartsine Technologies, Limited
Key facts
| Recall number (Z-number) | Z-2115-2014 |
|---|---|
| Recall event | 68703 |
| 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… |
| Product code | MKJ |
| Recalling firm | Heartsine Technologies, Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2015 |
| 510(k) numbers | K052465, K123881 |
| FEI number | 3004123209 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database