Xintec OptiLITE Laser Fiber Assembly Recall Due to Programming Error
Xintec Corp is recalling 45 OptiLITE laser fiber assemblies because they were programmed incorrectly. The devices will produce an error and prevent laser use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the defect results in the device failing to operate (producing an error) rather than causing a safety hazard or injury.
Plain-English summary
Xintec Corp is recalling 45 units of OptiLITE, Products for Laser Surgery, Model # CGH1080F. These are 800 micron single-use holmium fiber assemblies with flat tips, identified by Lot Number 21144 and UDI 00855430006036. The devices were sterilized by Sterrad Run 4149 and have a use-by date of 08/10/2021.
The recall was initiated because the fiber lasers in this lot were programmed incorrectly. As a result, the fibers will produce an error message and will not allow the user to operate the laser when plugged in. This is a functional defect that prevents the device from performing its intended function.
The affected units were distributed in Pennsylvania (PA) and Virginia (VA). Users of these specific laser fiber assemblies should stop using them and contact Xintec Corp for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Xintec Corp
- Hazard
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 21144
- Use by 08/10/2021
Distribution
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