Device recall
Z-2582-2021: Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL…
FDA device recall · Class I · North Coast Medical Inc
Key facts
| Recall number (Z-number) | Z-2582-2021 |
|---|---|
| Recall event | 88613 |
| Product | Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5… |
| Product code | ITX |
| Recalling firm | North Coast Medical Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K955246 |
| FEI number | 1000124207 |
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