Reported Oct 30, 2019 · Terminated
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot…
Xintec Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Xintec Corp · 1660 S Loop Rd · Alameda, CA · 94502-7091
Is this the product you have?
- 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
- UDI00855430006036
- Lot codes and dates
Lot # 21144Use by 08/10/2021
- Amount recalled
- 45 lasers
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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