Device recall
Z-0563-2009: Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000…
FDA device recall · Class II · Sterilmed Inc
Key facts
| Recall number (Z-number) | Z-0563-2009 |
|---|---|
| Recall event | 49510 |
| Product | Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140 An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway. |
| Product code | CAE |
| Recalling firm | Sterilmed Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 26, 2011 |
| FEI number | 3001237663 |
At a glance
- None Linked 510(k)s
- 10–99 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