Recall Z-1535-2017— Tearscience, Inc
Class II · Terminated
Class II FDA medical device recall by Tearscience, Inc, initiated 2017-01-30, terminated 2017-11-27. It names 3 FDA 510(k) clearances: K161357, K133127, K112704. Product: LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile. Reason: Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration..
- Recalling firm
- Tearscience, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-30
- Terminated
- 2017-11-27
- Firm location
- Morrisville, NC, United States
510(k) clearances named in this recall
3 on FDA's record- K161357 — LipiFlow Thermal Pulsation System
- K133127 — LIPIFLOW THERMAL PULSATION SYSTEM
- K112704 — LIPIFLOW THERMAL PULSATION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Reason for recall
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.