Reported Aug 9, 2017 · Terminated
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by…
Xintec Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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(TM) Products for Laser Surgery
- Catalog NumbersHTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system
- Lot codes and dates
- all codes.
- Amount recalled
- 4343 units
Where it was sold
- Nationwide
Why it was recalled
It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.
This product could cause temporary or reversible health problems — stop using it.
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