Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Reason for recall: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. Distribution: Domestic distribution to FL, KY, MA, NJ, NY, and PA Quantity: 24 incorrectly repaired units Lot/code info: UDI-DI 04953170305115 Serial Numbers 2635812, 2416423
04953170305115
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.