Device recall
Z-1256-2011: Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen…
FDA device recall · Class II · Convatec Inc.
Key facts
| Recall number (Z-number) | Z-1256-2011 |
|---|---|
| Recall event | 57626 |
| Product | Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREX Aerosol Mask Adult Elongated Manufactured for PSS World Medical Inc. RESPIREX Nebulizer Kits w/Aerosol Mask Adult 7 ft. (2.1m) Aerosol Tubing… |
| Product code | BYG |
| Recalling firm | Convatec Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 27, 2013 |
| FEI number | 3011987967 |
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