Device recall
Z-0093-2017: LipiFlow thermal Pulsation System, consisting of Console and Activator, Model…
FDA device recall · Class II · Tearscience, Inc
Key facts
| Recall number (Z-number) | Z-0093-2017 |
|---|---|
| Recall event | 75163 |
| Product | LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the… |
| Product code | ORZ |
| Recalling firm | Tearscience, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2017 |
| 510(k) numbers | K093937 |
| FEI number | 3008169506 |
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