Device recall
Z-2143-2023: HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately…
FDA device recall · Class II · HeartSine Technologies Ltd
Key facts
| Recall number (Z-number) | Z-2143-2023 |
|---|---|
| Recall event | 92346 |
| Product | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P |
| Product code | MKJ |
| Recalling firm | HeartSine Technologies Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P160008 |
| FEI number | 3004123209 |
At a glance
- None 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