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Clarus Dual HDMI Enclosure
CLARUS MEDICAL, LLC · Model CD-HDMI · UDI-DI 10810004820804
4
510(k) clearances
674
Adverse events
24
Recalls
234
Facilities
Description
The Clarus Dual HDMI Enclosure is a device used with a with a Clarus Digital Inspection Scope and is intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The Clarus Dual HDMI Enclosure provides a white light source and facilitates the image from the camera sensor to a monitor. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-02 | Healthmark Industries Co., Inc. | During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their inve |
| 2025-05-02 | Healthmark Industries Co., Inc. | During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their inve |
| 2024-01-09 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 De |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2022-04-21 | MEDLINE INDUSTRIES, LP - Northfield | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination. |
| 2020-07-09 | Medline Industries Inc | Potential risk of brush detachment during cleaning. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.