Device recall
Z-2164-2021: Semi-automatic Biopsy-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-2164-2021 |
|---|---|
| Recall event | 88213 |
| Product | Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article… |
| 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