Device recall
Z-1085-2015: LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use…
FDA device recall · Class II · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-1085-2015 |
|---|---|
| Recall event | 70258 |
| Product | LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and… |
| Product code | CAE |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2016 |
| FEI number | 3005747797 |
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