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CIDEX™ 2266Recalls & reported problems

Advanced Sterilization Products Services Inc. · CIDEX™ Activated Dialdehyde 4.7 Liter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705037044580), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Reprocessing Problem1
  • Failure to Disinfect1

Patient problems

  • HIV, Human Immunodeficiency Virus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 15, 2018Device Reprocessing Problem; Failure to Disinfect; Device Reprocessing Problem; Failure to Disinfect

    ADVANCED STERILIZATION PRODUCTS (ASP) BECAME AWARE A PATIENT TESTED (B)(6) FOR (B)(6) AND WAS DIAGNOSED IN (B)(6) 2013 WITH ACQUIRED IMMUNE DEFICIENCY SYNDROME. IT WAS REPORTED A COLONOSCOPY PROCEDURE WAS PERFORMED IN (B)(6) 2011, USING AN OLYMPUS COLONOSCOPE (NON-ASP PRODUCT) WHICH WAS REPROCESSED IN CIDEX SOLUTION. ON (B)(6) 2004 (REVISED ON (B)(6) 2004), ATS LABS PREPARED PROTOCOL # (B)(6) FOR ASP, TITLED ¿VIRUCIDAL EFFICACY OF DISINFECTANTS FOR USE ON INANIMATE ENVIRONMENTAL SURFACES ¿ VIRUS: (B)(6) TYPE 1¿. THE CONCLUSION OF THIS STUDY WAS THAT CIDEX DEMONSTRATED COMPLETE INACTIVATION OF (B)(6) TYPE 1 AS REQUIRED BY THE UNITED STATES (B)(4) FOR VIRUCIDAL LABEL CLAIMS. ASP MADE A DECISION TO FILE A FDA MEDWATCH REPORT OUT OF AN ABUNDANCE OF CAUTION; HOWEVER, ASP DOES NOT BELIEVE THE PATIENT DIAGNOSIS WAS RELATED TO USE OF CIDEX DURING SCOPE REPROCESSING.

    Patient problems: HIV, Human Immunodeficiency Virus

    MAUDE report 7606148 ↗

Other Sterilant, medical devices devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.