Device recall
Z-0272-2014: Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief…
FDA device recall · Class II · GlaxoSmithKline, LLC.
Key facts
| Recall number (Z-number) | Z-0272-2014 |
|---|---|
| Recall event | 66689 |
| Product | Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth |
| Product code | LFD |
| Recalling firm | GlaxoSmithKline, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2017 |
| 510(k) numbers | K123731 |
| FEI number | 1033964 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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