Pcf-h190dl recall: Contamination
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Why was Pcf-h190dl recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 04953170363672 Serial Numbers 2942716, 2604497, 2502056
- Product
- PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Recalling firm
- Aizu Olympus Co., Ltd.
- Quantity
- 24 incorrectly repaired units
- Distribution
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- Recall date
- December 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)