Device recall
Z-2795-2020: Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO…
FDA device recall · Class II · Bioseal Corporation
Key facts
| Recall number (Z-number) | Z-2795-2020 |
|---|---|
| Recall event | 85288 |
| Product | Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask. |
| Product code | BZA |
| Recalling firm | Bioseal Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2021 |
| FEI number | 2027062 |
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