Olympus Corporation of the Americas recalls EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT
Recalled Product
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Hazard / Issue
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060
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