Device recall
Z-2163-2021: Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the…
FDA device recall · Class II · INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Key facts
| Recall number (Z-number) | Z-2163-2021 |
|---|---|
| Recall event | 88213 |
| Product | Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no… |
| Product code | GAA |
| Recalling firm | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3014408997 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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