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1101 - Xi RACS tray with adapters (6)
Ultra Clean Systems, Inc. · Model 1101 · UDI-DI 10816634020263
10
510(k) clearances
232
Adverse events (2 deaths)
7
Recalls
151
Facilities
Description
Xi RACS tray with adapters (6) for Model 1101
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-31 | Ultra Clean Systems, Inc. | During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. |
| 2024-08-23 | Young Dental Manufacturing I, LLC | The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination. |
| 2020-11-19 | Steris Corporation | STERIS 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 |
| 2020-06-26 | Steris Corporation | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. |
| 2007-07-03 | Pacific 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. |
| 2006-06-22 | Steris Corporation | Smoke, 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 |
| 2006-06-22 | Steris Corporation | Smoke, 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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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.