FDAOctober 29, 2017device
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
What to do
FDA enforcement status: Terminated
Brands named
xintec
UPCs
00855430006036
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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