Z-0418-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 incorrectly repaired units
Product Description
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
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 Pattern
Domestic distribution to FL, KY, MA, NJ, NY, and PA
Code Information
UDI-DI 04953170363672 Serial Numbers 2942716, 2604497, 2502056