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Valsure

STERIS CORPORATION · Model 1C5002 · UDI-DI 00724995088712

FLG
10
510(k) clearances
235
Adverse events (2 deaths)
7
Recalls
155
Facilities

Description

Valsure Alkaline Detergent 30 Gallon is formulated to be used in manual and automated cleaning, including ultrasonic cleaners, washer disinfectors and other similar equipment.

Recalls

DateFirmReason
2025-03-31Ultra Clean Systems, Inc.During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
2024-08-23Young Dental Manufacturing I, LLCThe bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
2020-11-19Steris CorporationSTERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the dete
2020-06-26Steris CorporationA recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
2007-07-03Pacific Bioscience Lab, Inc.Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.
2006-06-22Steris CorporationSmoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result i
2006-06-22Steris CorporationSmoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result i

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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.