Device recall
Z-1845-2020: Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF…
FDA device recall · Class II · TeDan Surgical Innovations LLC
Key facts
| Recall number (Z-number) | Z-1845-2020 |
|---|---|
| Recall event | 85360 |
| Product | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices… |
| Product code | GEA |
| Recalling firm | TeDan Surgical Innovations LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2021 |
| FEI number | 3005726885 |
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