Drug recall
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal…
FDA recall event 75163 · Class II · Tearscience, Inc
Key facts
| Event ID | 75163 |
|---|---|
| Recall numbers | Z-0093-2017 |
| Recalling firm | Tearscience, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. |
| Initiation date | Sep 13, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | Feb 9, 2017 |
| City | Morrisville |
| State | NC |
| Country | United States |
| FEI number | 3008169506 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: