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HIP Ultra Cleaning Solution

Dent4You AG · Model CS-HIPC-U · UDI-DI 07640397420390

LDS

510(k) clearances

Adverse events

Recalls

Facilities

Description

HIP Ultra Cleaning Solution with Instrument Protection. For the Hydrim C61 and Eschmann Little Sister.

Recalls

Date	Firm	Reason
2018-04-09	Cenorin, LLC	There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
2016-04-22	Natus Medical Incorporated	The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during
2014-04-24	Cenorin, LLC	Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid dur
2013-01-24	Cenorin, LLC	The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pa
2010-06-07	Cenorin	The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it pr
2010-06-07	Cenorin	The water level sensor in the Medical Device Cleaning and High Level Disinfection (Washer/Pasteurizer) is sensitive to externally induced vibration noise, and it produces a false
2010-06-07	Cenorin	The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it pr
2010-06-07	Cenorin	The water level sensor switch in the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) is sensitive to externally induced vibration noise, and it pr
2006-12-21	Cenorin	Potential for user to receive an electrical shock.
2006-12-21	Cenorin	Potential for user to receive an electrical shock.

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Data 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.