CIDEXRecalls & reported problems across all models
Advanced Sterilization Products Services Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 4 models of CIDEX by Advanced Sterilization Products Services Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between May 24, 2018 and Jan 5, 2024 — classified as 1 injury, 42 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (19 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CIDEX problems
Device problems
- Improper or Incorrect Procedure or Method19
- Use of Device Problem11
- Problem with Sterilization9
- Failure to Disinfect6
- Device Handling Problem5
- Expiration Date Error2
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
Patient problems
- Burning Sensation14
- Skin Discoloration14
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient4
- HIV, Human Immunodeficiency Virus1
- Insufficient Information1
CIDEX models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CIDEX™ 20390Sterilant, medical devices33 reports
- CIDEX™ 20392Indicator, physical/chemical sterilization process6 reports
- Cidex™ 20398Sterilant, medical devices3 reports
- CIDEX™ 2266Sterilant, medical devices1 report
Recent CIDEX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2024Device Handling Problem; Device Handling Problem
A CUSTOMER REPORTED AN EVENT WHERE AN EXPIRED NON-ASP TEST STRIP, MANUFACTURED BY MCKESSON INDICATOR STRIP, WAS USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION. IT WAS REPORTED THAT A VAGINAL PROBE WAS PROCESSED IN THE AFFECTED SOLUTION AND WAS RELEASED AND USED ON A PATIENT DURING SURGERY. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENT ASSOCIATED WITH THIS EVENT. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18460513 ↗MalfunctionOct 10, 2023Device Handling Problem; Device Handling Problem
A CUSTOMER REPORTED AN EXPIRED CIDEX¿ OPA TEST STRIP WAS USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION. NO PERFORMANCE ISSUES WERE REPORTED; THE CUSTOMER STATED, ¿THE RESULT WAS AS EXPECTED,¿ AND THE AFFECTED LOAD WAS RELEASED FOR PATIENT USE. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED, AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17905623 ↗MalfunctionAug 26, 2022Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED AN EVENT WHERE EXPIRED CIDEX¿ OPA TEST STRIPS WERE USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION, AND TWO AFFECTED PROBES WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENTS ASSOCIATED WITH THIS ISSUE. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15303517 ↗MalfunctionJul 19, 2022Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED TWO EVENTS WHERE EXPIRED CIDEX¿ OPA TEST STRIPS WERE USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION, AND THE AFFECTED SCOPES WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENTS ASSOCIATED WITH THIS ISSUE. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE SECOND EVENT AT THE CUSTOMER FACILITY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2022-00210 FOR THE FIRST EVENT RELATED TO THIS USE ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15060140 ↗MalfunctionJul 19, 2022Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED TWO EVENTS WHERE EXPIRED CIDEX¿ OPA TEST STRIPS WERE USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION, AND THE AFFECTED SCOPES WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENTS ASSOCIATED WITH THIS ISSUE. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE FIRST EVENT AT THE CUSTOMER FACILITY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2022-00211 FOR THE SECOND EVENT RELATED TO THIS USE ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15060114 ↗MalfunctionJun 15, 2022Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED AN EVENT OF MULTIPLE USE ERRORS IDENTIFIED AT THEIR FACILITY INVOLVING INSTRUMENT REPROCESSING WITH CIDEX® OPA SOLUTION. THE CUSTOMER STATED THAT APPROXIMATELY SINCE (B)(6) 2022, THE FACILITY HAD BEEN REPROCESSING WITH CIDEX® OPA SOLUTION WITHOUT MONITORING THE TEMPERATURE OR USING THE TEST STRIPS TO CHECK THE MINIMUM EFFECTIVE CONCENTRATION (MEC), AND THE FACILITY REPLACES THE CIDEX® OPA SOLUTION EVERY 30 DAYS INSTEAD OF THE MAXIMUM 14 DAYS OF REUSE AS PER THE CIDEX® OPA INSTRUCTIONS FOR USE (IFU). LASTLY, THE CUSTOMER REPORTED INSTRUMENTS WERE RELEASED AND USED ON PATIENT(S). HOWEVER; THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY RELATED TO THESE STATED USE ERRORS, AS A MATTER OF POLICY, ASP HAS DECIDED TO REPORT ALL THESE INCIDENTS WHEN THE INVOLVED DEVICES HAVE BEEN RELEASED FOR USE ON PATIENT(S).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14698979 ↗MalfunctionJun 14, 2022Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED AN EVENT OF MEDICAL INSTRUMENT CORROSION, AND THAT A HEALTHCARE WORKER (HCW) EXPERIENCED BLUE SKIN DISCOLORATION ON THE HANDS WHEN PROCESSING WITH CIDEX® OPA SOLUTION. THE BLUE SKIN DISCOLORATION LASTED FOR ONE DAY AND RESOLVED WITH SEVERAL HAND WASHINGS, AND THE CUSTOMER REPORTED THAT ¿NO ADVERSE SKIN REACTIONS¿ OCCURRED, ONLY ¿TEMPORARY STAINING¿. IN ADDITION, THE CUSTOMER REPORTED INSTRUMENTS WERE RELEASED AND USED ON PATIENT(S); HOWEVER, THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. THE HCW PROVIDED ADDITIONAL EVENT INFORMATION THAT STATED THE MEDICAL INSTRUMENTS/TOOLS WERE FIRST OBSERVED TO BE ¿DAMAGED¿ ON (B)(6) 2022. THE HCW REPORTED THAT THE MEDICAL INSTRUMENTS WERE IMMERSED IN CIDEX® OPA SOLUTION FOR TWO TO FIVE MINUTES, THEN THE INSTRUMENTS WERE PLACED ON PAPER TO AIR DRY. THE HCW ALSO REPORTED THAT NO TEST STRIPS WERE USED TO MEASURE THE MINIMUM EFFECTIVE CONCENTRATION (MEC), AND THE SOLUTION TEMPERATURE WAS NOT MONITORED. BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, MULTIPLE USE ERRORS HAVE BEEN IDENTIFIED PER THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU). THE REPORTED SKIN REACTION HAS
Patient problems: Skin Discoloration
MAUDE report 14686374 ↗MalfunctionJun 14, 2022Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED AN EVENT OF MEDICAL INSTRUMENT CORROSION, AND THAT A HEALTHCARE WORKER (HCW) EXPERIENCED BLUE SKIN DISCOLORATION ON THE HANDS WHEN PROCESSING WITH CIDEX® OPA SOLUTION. THE BLUE SKIN DISCOLORATION RESOLVED IN THREE DAYS WITH HAND WASHING AND THE USE OF ALCOHOL, AND THE CUSTOMER REPORTED THAT ¿NO ADVERSE SKIN REACTIONS¿ OCCURRED, ONLY ¿TEMPORARY STAINING¿. IN ADDITION, THE CUSTOMER REPORTED INSTRUMENTS WERE RELEASED AND USED ON PATIENT(S); HOWEVER, THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. THE HCW PROVIDED ADDITIONAL EVENT INFORMATION THAT STATED THE MEDICAL INSTRUMENTS/TOOLS WERE FIRST OBSERVED TO BE ¿DAMAGED¿ IN (B)(6) 2021, APPROXIMATELY WHEN THE FACILITY BEGAN USING CIDEX® OPA. THE HCW REPORTED THAT THE MEDICAL INSTRUMENTS WERE IMMERSED IN CIDEX® OPA SOLUTION FOR FIVE TO EIGHT MINUTES, THEN THE INSTRUMENTS WERE PLACED ON A PAPER TOWEL TO DRY. THE HCW INDICATED THAT NO TEST STRIPS WERE USED TO MEASURE THE MINIMUM EFFECTIVE CONCENTRATION (MEC), AND THE SOLUTION TEMPERATURE WAS NOT MONITORED. THE ADDITIONAL INFORMATION ALSO INDICATED THAT TOOLS/INSTRUMENTS WERE STORED OR KEPT IN CIDEX® OPA SOLUTION FOR 12 HOURS; HOWE
Patient problems: Skin Discoloration
MAUDE report 14686117 ↗MalfunctionDec 20, 2021Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED AN EVENT OF CIDEX® OPA SOLUTION BEING USED AT 17.2 DEGREES CELSIUS TO REPROCESS A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEEC) PROBE, AND THE PROBE WAS RELEASED AND USED ON A PATIENT. AS PER THE CIDEX® OPA INSTRUCTIONS FOR USE (IFU), THE MINIMUM TEMPERATURE FOR REPROCESSING IS 20 DEGREES CELSIUS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT ALL INCIDENTS OF CIDEX® OPA SOLUTION BEING USED UNDER THE MINIMUM REPROCESSING TEMPERATURE AND THE INSTRUMENT WAS RELEASED AND USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046511 ↗MalfunctionDec 6, 2021Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED THAT THEIR FACILITY DID NOT FOLLOW THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) FOR INSTRUMENT RINSING, AND THE INSTRUMENTS WERE RELEASED AND USED ON PATIENTS. THE FACILITY CONFIRMED THERE WERE NO PATIENT SYMPTOMS AND NO INJURIES REPORTED. PER THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU), A MINIMUM OF THREE ONE-MINUTE RINSES ARE REQUIRED USING LARGE VOLUMES OF FRESH WATER. IT WAS REPORTED THAT THERE WAS HUMAN CONTACT WITH A MEDICAL DEVICE THAT WAS NOT RINSED PER CIDEX® OPA SOLUTION IFU; THEREFORE, THIS EVENT IS BEING REPORTED AS A MALFUNCTION SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12936937 ↗MalfunctionNov 30, 2021Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED AN EVENT OF TWO PATIENTS EXPERIENCED ADVERSE URINARY REACTIONS POST CYSTOSCOPY PROCEDURES WITH INSTRUMENTS THAT WERE REPROCESSED WITH CIDEX OPA SOLUTION. ONE OF THE TWO PATIENTS REPORTED BURNING SENSATION RIGHT AFTER THE PROCEDURE; HOWEVER, IT IS UNCLEAR WHICH OF THE TWO PATIENTS EXPERIENCED THE IMMEDIATE REACTION. THE CUSTOMER STATED THAT THE INCIDENT IS NOT CONSIDERED A SERIOUS INJURY AND REPORTED THAT THE PATIENTS ARE "FINE". THIS REPORT IS FOR A PATIENT WITH BLADDER CANCER WHO UNDERWENT A CYSTOSCOPY WITH A WOLF FLEXIBLE CYSTOSCOPE. THE PATIENT RECEIVED A LOCAL ANESTHETIC (5% LIDOCAINE JELLY) INJECTED INTO THE URETHRA. THE PATIENT EXPERIENCED BURNING URETHRA WHILE URINATING POST PROCEDURE. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ORAL ANTIBIOTICS; HOWEVER, IT IS NOT KNOWN IF THESE ANTIBIOTICS ARE GIVEN TO ALL CYSTOSCOPY PATIENTS. ADDITIONALLY, IT WAS RECOMMENDED TO TAKE AZO, WHICH IS AN ORAL OVER-THE-COUNTER (OTC) MEDICATION, TO RELIEVE THE BURNING SENSATION. IT IS NOT KNOWN IF THE PATIENT TOOK THIS OTC MEDICATION OR THE DURATION OF TREATMENT. THE CUSTOMER PROVIDED THAT THE INSTRUMENTS REPROCESSING PROCEDURE INCLUDED IMMERSION IN A DILUTED NON-ASP DETERGENT (P
Patient problems: Burning Sensation
MAUDE report 12903020 ↗MalfunctionNov 30, 2021Use of Device Problem; Use of Device Problem
A CUSTOMER REPORTED AN EVENT OF TWO PATIENTS EXPERIENCED ADVERSE URINARY REACTIONS POST CYSTOSCOPY PROCEDURES WITH INSTRUMENTS THAT WERE REPROCESSED WITH CIDEX OPA SOLUTION. ONE OF THE TWO PATIENTS REPORTED BURNING SENSATION RIGHT AFTER THE PROCEDURE; HOWEVER, IT IS UNCLEAR WHICH OF THE TWO PATIENTS EXPERIENCED THE IMMEDIATE REACTION. THE CUSTOMER STATED THAT THE INCIDENT IS NOT CONSIDERED A SERIOUS INJURY AND REPORTED THAT THE PATIENTS ARE "FINE". THE PATIENT RECEIVED A LOCAL ANESTHETIC (5% LIDOCAINE JELLY) INJECTED INTO THE URETHRA PRIOR TO THE CYSTOSCOPY WITH A WOLF FLEXIBLE CYSTOSCOPE. THE PATIENT EXPERIENCED BURNING URETHRA WHILE URINATING POST PROCEDURE. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ORAL ANTIBIOTICS; HOWEVER, IT IS NOT KNOWN IF THESE ANTIBIOTICS ARE GIVEN TO ALL CYSTOSCOPY PATIENTS. ADDITIONALLY, IT WAS RECOMMENDED TO TAKE AZO, WHICH IS AN ORAL OVER-THE-COUNTER (OTC) MEDICATION, TO RELIEVE THE BURNING SENSATION. IT IS NOT KNOWN IF THE PATIENT TOOK THIS OTC MEDICATION OR THE DURATION OF TREATMENT. THE CUSTOMER PROVIDED THAT THE INSTRUMENTS REPROCESSING PROCEDURE INCLUDED IMMERSION IN A DILUTED NON-ASP DETERGENT (PROLYSTICA), THEN IMMERSION IN CIDEX® OPA SOLUTION, AN
Patient problems: Burning Sensation
MAUDE report 12903017 ↗MalfunctionNov 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A CUSTOMER REPORTED THAT HIS FACILITY IS NOT FOLLOWING THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) FOR MINIMUM TEMPERATURE AND DEVICE RINSING, AND HE HAD CONTACTED ADVANCED STERILIZATION PRODUCTS (ASP) FOR CONFIRMATION OF THE CORRECT PROCESS. HE REPORTED THAT AS PER THE FACILITY¿S INSTRUCTIONS, CIDEX® OPA SOLUTION WAS USED TO REPROCESS INSTRUMENTS WHEN IT WAS BELOW MINIMUM TEMPERATURE OF 68 DEGREES FAHRENHEIT, AND THE FACILITY ALSO REUSED THE RINSE WATER. ASP CONFIRMED AND ADVISED THE CUSTOMER THAT THE MINIMUM TEMPERATURE FOR CIDEX® OPA SOLUTION MANUAL PROCESSING IS 68 DEGREES FAHRENHEIT, AND THE RINSE WATER SHOULD BE DISCARDED AFTER EACH RINSE. THE CUSTOMER CONFIRMED THAT THE INCORRECTLY PROCESSED INSTRUMENTS WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED, ASP HAS DECIDED TO REPORT ALL INCIDENTS OF CIDEX® OPA SOLUTION BEING USED BELOW THE MINIMUM TEMPERATURE, WITH THE AFFECTED INSTRUMENTS RELEASED AND USED ON PATIENTS. IT WAS ALSO REPORTED THAT THERE WAS HUMAN CONTACT WITH A MEDICAL DEVICE THAT WAS NOT RINSED PER CIDEX® OPA SOLUTION IFU; THEREFORE, THIS EVENT I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12865225 ↗MalfunctionNov 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A CUSTOMER REPORTED AN EVENT OF EXPIRED CIDEX OPA CONCENTRATE BEING USED TO REPROCESS INSTRUMENTS, WHICH WERE RELEASED FOR USE ON PATIENTS. THE EXPIRED DISINFECTANT WAS IN USE FOR APPROXIMATELY FOUR WEEKS BEFORE THE ERROR WAS DISCOVERED, AND THE AFFECTED INSTRUMENTS WERE RELEASED AND USED ON 13 PATIENTS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT ALL CASES WHERE A CUSTOMER USES EXPIRED PRODUCT AND RELEASES IT FOR USE ON PATIENTS SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THE EXPIRED CIDEX OPA CONCENTRATE WAS USED IN TWO EVOTECH¿ ECRS AT THIS FACILITY. THIS REPORT IS FOR EVOTECH #2 AND PATIENT #2, REFER TO THE MANUFACTURER REPORT NUMBER 2084725-2021-00434 FOR THE REPORT ON EVOTECH #1 AND PATIENT #1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12861933 ↗MalfunctionNov 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A CUSTOMER REPORTED AN EVENT OF EXPIRED CIDEX OPA CONCENTRATE BEING USED TO REPROCESS INSTRUMENTS, WHICH WERE RELEASED FOR USE ON PATIENTS. THE EXPIRED DISINFECTANT WAS IN USE FOR APPROXIMATELY FOUR WEEKS BEFORE THE ERROR WAS DISCOVERED, AND THE AFFECTED INSTRUMENTS WERE RELEASED AND USED ON 13 PATIENTS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT ALL CASES WHERE A CUSTOMER USES EXPIRED PRODUCT AND RELEASES IT FOR USE ON PATIENTS SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THE EXPIRED CIDEX OPA CONCENTRATE WAS USED IN TWO EVOTECH¿ ECRS AT THIS FACILITY. THIS REPORT IS FOR EVOTECH¿ #1 AND PATIENT #1, REFER TO THE MANUFACTURING REPORT NUMBER 2084725-2021-00435 FOR THE REPORT ON EVOTECH¿ #2 AND PATIENT #2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12861932 ↗
Other Advanced Sterilization Products Services Inc. products
All Advanced Sterilization Products Services Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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