Device recall
Z-1451-2013: Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P…
FDA device recall · Class II · Maytex Corp
Key facts
| Recall number (Z-number) | Z-1451-2013 |
|---|---|
| Recall event | 65160 |
| Product | Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures. |
| Product code | FXX |
| Recalling firm | Maytex Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 29, 2013 |
| 510(k) numbers | K964358 |
| FEI number | 2939286 |
At a glance
- 1–9 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