Drug recall
Bivona Aire-Cuf Endotracheal Tube
FDA recall event 88512 · Class II · Smiths Medical ASD Inc.
Key facts
| Event ID | 88512 |
|---|---|
| Recall numbers | Z-0177-2022, Z-0178-2022 |
| Recalling firm | Smiths Medical ASD Inc. |
| Product type | Devices |
| Products | Bivona Aire-Cuf Endotracheal Tube, Bivona Uncuffed Wire Endotracheal Tubes, |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. |
| Initiation date | Aug 9, 2021 |
| Report date | Nov 3, 2021 |
| Termination date | Oct 13, 2023 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3012307300 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: