Device recall
Z-0385-2017: LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product…
FDA device recall · Class II · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-0385-2017 |
|---|---|
| Recall event | 75554 |
| Product | LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight… |
| Product code | BTR |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2020 |
| 510(k) numbers | K021044 |
| FEI number | 3005747797 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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