STERRAD™ 10144Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705037014903), received between Feb 9, 2018 and Jan 2, 2025 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (21 reports).

6 other recalls cover devices cleared under the same FDA submission (K071385, K092622, K111377, K160903, K212174, K234082); they may or may not involve this specific model.

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

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) IN HER FIFTIES EXPERIENCED A ¿LOW-TEMPERATURE BURN¿ WHEN SHE OPENED A NEW STERRAD® 100NX CASSETTE PACKAGE. THE HCW WAS WEARING WATERPROOF GLOVES, BUT SHE DID NOT WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE). THE HYDROGEN PEROXIDE LEAKED DOWN HER ARM AND THE SKIN TURNED WHITE. SHE WASHED THOROUGHLY WITH RUNNING WATER AND THE H2O2 SKIN REACTION LASTED ONE DAY. SHE DID NOT RECEIVE MEDICAL ATTENTION, AND IT WAS REPORTED SHE ¿TOTALLY RECOVERED¿. THE H2O2 ¿LOW-TEMPERATURE BURN" WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 21060192 ↗
• MalfunctionAug 27, 2024Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED A SKIN REACTION OF TINGLING SENSATION WHEN SHE PUT HER BARE PALM DOWN ON THE COUNTER WHERE TWO USED STERRAD® 100NX CASSETTES HAD BEEN PREVIOUSLY LAYING FOR DISPOSAL. SHE DID NOT TOUCH THE ACTUAL CASSETTES. IT WAS REPORTED NO RESIDUAL H2O2 LIQUID FROM THE CASSETTES WAS NOTED ON THE COUNTER NOR ON THE USED CASSETTES. THE AFFECTED AREA WAS WASHED, AND NO MEDICAL TREATMENT WAS RECEIVED. THE AFFECTED AREA WAS WASHED, AND NO MEDICAL TREATMENT WAS RECEIVED THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Burning Sensation; Skin Discoloration

  MAUDE report 20081750 ↗
• MalfunctionAug 27, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A COMPANY REPRESENTATIVE EXPERIENCED A H2O2 SKIN REACTION OF A "TINGLING" SENSATION AND WHITE DISCOLORATION WHEN TAKING OUT TWO STERRAD® 100NX CASSETTES OUT OF THE COLLECTION BOX FOR DISPOSAL, WITHOUT GLOVES. NO RESIDUAL H2O2 WAS NOTED IN THE USED CASSETTES, THE COLLECTION BOX, NOR THE COUNTER. THE AFFECTED AREA WAS RINSED IMMEDIATELY WITH WATER, THEN WASHED. THE WHITE DISCOLORATION WAS GONE IN TWO HOURS AND THE SENSATION LASTED 30-45 MINUTES. NO MEDICAL TREATMENT WAS NEEDED, AND HE STATED HE WAS "FINE". THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Burning Sensation; Skin Discoloration

  MAUDE report 20081574 ↗
• MalfunctionAug 15, 2024Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A MALE HEALTH CARE WORKER (HCW) EXPERIENCED A "H2O2 BURN" WHEN HE REMOVED A USED STERRAD® 100NX CASSETTE FROM THE COLLECTION BOX WITHOUT GLOVES. THE AFFECTED AREA ON HIS HAND TURNED WHITE, BUT THE SKIN REACTION RESOLVED, AND HE IS REPORTED "OKAY". HE VISITED THE DOCTOR/CLINICIAN; HOWEVER, IT IS IT IS UNKNOWN IF MEDICAL TREATMENT WAS RECEIVED. THE "H2O2 BURN" WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 19994101 ↗
• MalfunctionMay 17, 2024Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A FEMALE HEALTHCARE WORKER (HCW) EXPERIENCED ¿BURNS¿ RELATED TO A STERRAD® 100NX CASSETTE. IT WAS REPORTED SHE HANDLED THE CASSETTE WITHOUT GLOVES AND NOTICED HER HANDS WERE WET, THEN SHE GAVE THE CASSETTE TO ANOTHER COLLEAGUE. THE H2O2 SKIN REACTION WAS WHITE ON HER HANDS AND RED ON ARMS, AND SHE RINSED WITH WATER AND THE REACTION RESOLVED IN 4-5 HOURS. IT WAS ALSO NOTED SHE HAD THROAT ¿IRRITATION¿ RELATED TO HANDLING THE CASSETTE THAT LASTED 4-5 HOURS. SHE RECEIVED MEDICAL ATTENTION FROM A DOCTOR IN THE HOSPITAL AND RECEIVED LORATADINE (ANTIHISTAMINE) AND DEXAMETHASONE (CORTICOSTEROID), WHICH CAN BE PURCHASED OVER-THE-COUNTER. LASTLY, IT WAS REPORTED SHE IS ¿WORKING AS USUAL¿ AND IS ¿FINE¿. THE H2O2 SKIN REACTION AND RESPIRATORY REACTION WERE ASSESSED TO BE A MINOR INJURY SINCE THERE IS NO REPORT THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2024-00018 FOR THE ADDITIONAL HCW INVOLVED IN THIS EVENT.

  Patient problems: Erythema; Skin Discoloration; Unspecified Respiratory Problem

  MAUDE report 19340481 ↗
• MalfunctionMay 17, 2024Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A MALE HEALTHCARE WORKER (HCW) EXPERIENCED ¿BURNS¿ RELATED TO A STERRAD® 100NX CASSETTE. IT WAS REPORTED HE HANDLED THE CASSETTE AFTER ANOTHER COLLEAGUE GAVE IT TO HIM, AND HE WAS NOT WEARING GLOVES. THE H2O2 SKIN REACTION WAS WHITE, AND HE WASHED WITH WATER AND SOAP AND THE REACTION RESOLVED IN 4-5 HOURS. HE RECEIVED MEDICAL ATTENTION FROM A DOCTOR IN THE HOSPITAL AND RECEIVED LORATADINE (ANTIHISTAMINE), PARACETAMOL (ACETAMINOPHEN), AND ¿CLOFERAMINA COMPUESTA¿ (ANTIHISTAMINE), WHICH CAN BE PURCHASED OVER-THE-COUNTER. LASTLY, IT WAS REPORTED HE IS ¿WORKING AS USUAL¿ AND IS ¿FINE¿. THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE THERE IS NO REPORT THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY. REFER TO MANUFACTURER REPORT NUMBER 2084725-2024-00017 FOR THE ADDITIONAL HCW INVOLVED IN THIS EVENT.

  Patient problems: Skin Discoloration

  MAUDE report 19340478 ↗
• MalfunctionDec 22, 2023Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A HEALTH CARE WORKER (HCW) CAME IN CONTACT WITH HYDROGEN PEROXIDE WHILE INSERTING A NEW STERRAD® 100NX CASSETTE WITHOUT WEARING GLOVES. THE HCW EXPERIENCED SKIN REACTIONS DESCRIBED AS ITCHINESS AND WHITE SKIN DISCOLORATION ON TWO FINGERS. IT WAS REPORTED THE HCW WENT TO THE EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN WHETHER MEDICAL INTERVENTION WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THE H2O2 SKIN REACTION WAS ASSESSED TO BE MINOR INJURY; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Itching Sensation; Skin Discoloration

  MAUDE report 18387007 ↗
• MalfunctionNov 3, 2023Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED ¿CHEMICAL BURNS¿ WHEN SHE REMOVED USED STERRAD® 100NX CASSETTE FROM THE COLLECTION BOX FOR DISPOSAL. IT WAS REPORTED THE HCW WAS NOT WEARING GLOVES. HER HAND TURNED WHITE, AND SHE REPORTED THE REACTION WENT AWAY IN A COUPLE HOURS. THE HCW WASHED THE AFFECTED AREA AND APPLIED LOTION, AND REPORTED SHE DID NOT SEEK MEDICAL ATTENTION FOR THE REACTION. THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 18069416 ↗
• MalfunctionSep 1, 2023Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A HEALTH CARE WORKER (HCW) EXPERIENCED A SKIN REACTION DESCRIBED AS WHITE MARKS ON THE HANDS WHEN HANDLING A NEW STERRAD® 100NX CASSETTE. IT WAS REPORTED THAT THE LEAK INDICATOR WAS ¿DISCOLORED,¿ AND THE HCW HANDLED THE CASSETTE WITHOUT WEARING GLOVES. THE AFFECTED AREAS WERE WASHED WITH WATER, AND THE SYMPTOMS RESOLVED WITHOUT REQUIRING MEDICAL TREATMENT. THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 17673867 ↗
• MalfunctionJul 28, 2023Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED A SKIN REACTION DESCRIBED AS WHITE MARKS ON THE HANDS WHEN HANDLING A USED STERRAD® 100NX CASSETTE. IT WAS REPORTED THERE WAS LIQUID LEFT IN THE CELLS, AND THE HCW HANDLED THE CASSETTE WITHOUT WEARING GLOVES. THE AFFECTED AREAS WERE IMMEDIATELY WASHED WITH WATER, AND THE SYMPTOMS RESOLVED WITHIN FOUR HOURS WITHOUT REQUIRING MEDICAL TREATMENT. THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 17418490 ↗
• MalfunctionJul 5, 2023Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A HEALTH CARE WORKER (HCW) EXPERIENCED A SKIN REACTION FROM DISCARDING A USED STERRAD® 100NX CASSETTE BY REMOVING THE CASSETTE FROM THE DISPOSAL COLLECTION BOX. THE HCW WAS NOT WEARING GLOVES AND MADE CONTACT WITH H2O2 ON THE LEFT HAND, PALM AND FINGERS. THE HCW SUFFERED A SKIN BURNING SENSATION AND A WHITE SKIN DISCOLORATION, AND THE AFFECTED AREA WAS IMMEDIATELY WASHED WITH WATER. THE HCW VISITED EMERGENCY ASSISTANCE PER OCCUPATIONAL ACCIDENT PROTOCOL, WHERE THE AFFECTED AREA WAS FURTHER RINSED WITH WATER AND VASELINE GAUZE WAS APPLIED TO THE ¿BURNING¿ AREA. THE SKIN REACTION LASTED SIX HOURS, AND THE HCW WAS REPORTED AS BEING ¿WELL¿ AND ¿OPERATING SMOOTHLY¿. THE INJURIES WERE ASSESSED TO BE MINOR SINCE THE H2O2 SKIN REACTION RESOLVED WITH FIRST-AID MINIMAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY DUE TO CONTACT WITH H2O2 FROM A STERRAD 100NX CASSETTE.

  Patient problems: Skin Burning Sensation; Skin Discoloration

  MAUDE report 17262543 ↗
• MalfunctionMar 16, 2023Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED A SKIN REACTION OF BURNING/TINGLING SENSATION AND DISCOLORATION ON THE HANDS WHEN REPLACING AN EJECTED STERRAD® 100NX CASSETTE FROM THE UNIT. IT WAS REPORTED NO DAMAGE OR LEAK WAS OBSERVED FOR THE NEW CASSETTE, AND THE HCW HANDLED THE CASSETTES WITHOUT WEARING GLOVES. THE AFFECTED AREAS WERE IMMEDIATELY WASHED WITH WATER, AND THE SYMPTOMS RESOLVED WITHIN TWO HOURS WITHOUT REQUIRING MEDICAL TREATMENT. THE H2O2 SKIN REACTION WAS ASSESSED TO BE A MINOR INJURY SINCE IT RESOLVED WITHOUT MEDICAL INTERVENTION; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Burning Sensation; Skin Discoloration

  MAUDE report 16556965 ↗
• MalfunctionOct 11, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A HEALTH CARE WORKER (HCW) EXPERIENCED ¿BURNS¿ ON THE HAND DUE TO CONTACT WITH HYDROGEN PEROXIDE FROM A USED STERRAD® 100NX CASSETTE THAT WAS IN A CASSETTE DISPOSAL COLLECTION BOX. IT WAS REPORTED THE SKIN REACTION DISAPPEARED AFTER AN HOUR, AND THE HCW DID NOT SEEK MEDICAL TREATMENT. THE INJURY RESOLVED WITHOUT MEDICAL INTERVENTION AND WAS DEEMED TO BE MINOR; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Burning Sensation

  MAUDE report 15584685 ↗
• MalfunctionSep 8, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A HEALTH CARE WORKER (HCW) HAD A SKIN REACTION FROM DISCARDING THE STERRAD® 100NX CASSETTES BY REMOVING THE CASSETTES FROM THE DISPOSAL COLLECTION BOX. THE HCW EXPERIENCED SKIN DISCOLORATION OF ¿WHITE SPOTS¿ ON THE INDEX FINGERS, LEFT THUMB, AND HER RIGHT PALM. THE HCW REPORTED WASHING THE AFFECTED AREAS WITH SOAP AND WATER, AND THE SKIN DISCOLORATION ON THE LEFT THUMB RESOLVED IMMEDIATELY, AND THE SPOTS WERE ¿ALL GONE¿ THE FOLLOWING MORNING. IT WAS REPORTED THE HCW WAS WEARING GLOVES, BUT IT WAS UNKNOWN IF HYDROGEN PEROXIDE CONTACT WAS DUE TO DAMAGE/DEFECT ON THE GLOVES OR FROM THE H2O2 ON THE GLOVES DURING DISPOSAL. THE HCW WENT TO THE EMERGENCY ROOM AND THE H2O2 SKIN REACTION WAS CHECKED, BUT NO TREATMENT WAS GIVEN OR REQUIRED. THE INJURIES WERE ASSESSED TO BE MINOR SINCE THE H2O2 SKIN REACTION RESOLVED WITHOUT MEDICAL TREATMENT; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 15384879 ↗
• MalfunctionJun 22, 2022Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED THAT A FEMALE HEALTH CARE WORKER (HCW) EXPERIENCED A HYDROGEN PEROXIDE BURN WHEN SHE HANDLED A USED STERRAD® 100NX CASSETTE THAT WAS NOT IN THE CASSETTE COLLECTION BOX FOR DISPOSAL. THE HCW DID NOT WEAR GLOVES AND SUFFERED A WHITE SKIN REACTION/DISCOLORATION ON HER INDEX FINGER. SHE REMOVED THE CHEMICAL WITH RUNNING WATER AND DID NOT RECEIVE MEDICAL TREATMENT. THE SKIN REACTION WAS REPORTED AS LASTING AT LEAST ONE DAY AND WAS ¿GETTING BETTER¿. THE REPORTED SKIN REACTION HAS BEEN DETERMINED TO BE A MINOR INJURY SINCE THERE WAS NO PERMANENT DAMAGE OR IMPAIRMENT, AND NO MEDICAL INTERVENTION WAS RECEIVED. HOWEVER; THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 14775114 ↗
• MalfunctionJun 7, 2022Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) HAD AN H2O2 SKIN REACTION AFTER REMOVING A STERRAD® 100NX CASSETTE FROM THE STERRAD® STERILIZER COLLECTION BOX. THE HCW EXPERIENCED PAIN IN THE FINGERTIPS AND THE SKIN TURNED WHITE. THE AFFECTED AREA WAS WASHED WITH RUNNING WATER, AND THE SKIN REACTION LASTED ONE DAY. THE HCW DID NOT RECEIVE MEDICAL TREATMENT AND WAS REPORTED AS ¿FULLY RECOVERED¿. THE HCW WAS WEARING GLOVES AT THE TIME OF THE EVENT; HOWEVER, THE H2O2 SKIN CONTACT OCCURRED WHEN THE HCW REMOVED THE GLOVES FOR DISPOSAL. THE INJURIES WERE ASSESSED TO BE MINOR SINCE THE H2O2 SKIN REACTION RESOLVED WITHOUT MEDICAL TREATMENT; HOWEVER, THE SKIN REACTION WAS DUE TO CONTACT WITH H2O2 FROM A STERRAD® 100NX CASSETTE; THEREFORE, THIS EVENT IS BEING REPORTED AS A MALFUNCTION SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Skin Burning Sensation; Skin Discoloration

  MAUDE report 14626866 ↗
• MalfunctionMar 15, 2022Fluid/Blood Leak; Device Handling Problem; Fluid/Blood Leak; Device Handling Problem

  A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) EXPERIENCED "COLD BURNS" OR SKIN REACTION WHEN SHE OPENED A NEW PACKAGE OF STERRAD® 100NX CASSETTE. THE HCW WAS NOT WEARING GLOVES WHEN SHE MADE CONTACT WITH HYDROGEN PEROXIDE (H2O2) WITHOUT NOTICING THE CHEMICAL INDICATOR STRIP HAD CHANGED COLOR TO RED, WHICH INDICATES H2O2 LEAKAGE HAS OCCURRED. THE LIQUID ADHERED TO HER HAND AND AFFECTED AN AREA ON HER PALM MEASURING APPROXIMATELY 10 CM. SHE WASHED THE AFFECTED AREA WITH WATER AND VISITED A DERMATOLOGIST, AND THE DOCTOR NOTED THE SKIN REACTION AS ¿MINOR¿ WITH NO RESIDUAL H2O2 PRESENT. THE DURATION OF THE SKIN REACTION LASTED ¿HALF DAY¿ AND THE HCW STATUS WAS UPDATED TO ¿NO PROBLEM¿ DUE TO APPROPRIATE MEASURES WERE TAKEN. THE H2O2 SKIN REACTION IS CONSIDERED NOT SERIOUS AND RESOLVED IN HALF A DAY AFTER WASHING THE AFFECTED AREA. THE DERMATOLOGIST NOTED THE INJURY TO BE ¿MINOR¿ AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Burning Sensation

  MAUDE report 13764996 ↗
• MalfunctionFeb 9, 2022Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED THAT A HEALTHCARE WORKER (HCW) EXPERIENCED A ¿BURN¿ FROM A HYDROGEN PEROXIDE SKIN CONTACT WHEN REMOVING A USED STERRAD® 100NX CASSETTE FROM THE UNIT. THE HCW WAS ONLY WEARING A GLOVE ON ONE HAND, AND THE SKIN REACTION OCCURRED ON THE UNPROTECTED HAND. THE H2O2 SKIN REACTION LASTED ONE DAY, AND THERE IS NO REPORT OF MEDICAL ATTENTION. LASTLY, IT WAS REPORTED THE HCW STATUS WAS ¿PAINLESS REMISSION¿. THE INFORMATION SUGGESTS THE H2O2 SKIN REACTION WAS NOT SERIOUS; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 13502191 ↗
• MalfunctionDec 13, 2021Leak/Splash; Device Handling Problem; Leak/Splash; Device Handling Problem

  A CUSTOMER REPORTED AN EVENT OF A LEAK FOR THE STERRAD® 100NX CASSETTE WITHOUT THE LEAK CHEMICAL INDICATOR STRIP CHANGING COLOR. A HEALTHCARE WORKER (HCW), WHO WAS NOT WEARING GLOVES, MADE SKIN CONTACT WITH THE HYDROGEN PEROXIDE WHEN OPENING THE CASSETTE PACKAGE AND EXPERIENCED ¿BURNED¿ FINGER. THE HCW WASHED WITH PLENTY OF WATER AND DID NOT RECEIVE MEDICAL TREATMENT FOR THE SKIN REACTION. LASTLY, THE SYMPTOMS LASTED ONE DAY AND THE HCW HAS RECOVERED. THE H2O2 SKIN REACTION RESOLVED WITHOUT MEDICAL TREATMENT AND IS NOT CONSIDERED A SERIOUS INJURY; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Skin Burning Sensation

  MAUDE report 12984922 ↗
• MalfunctionNov 19, 2021Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) RECEIVED A "LOW TEMPERATURE BURN" OR SKIN REACTION WHEN SHE OPENED A NEW PACKAGE OF STERRAD® 100NX CASSETTE. THE HCW WAS NOT WEARING GLOVES, AND SHE MADE CONTACT WITH HYDROGEN PEROXIDE BEFORE NOTICING THE H2O2 INDICATOR STRIP CHANGED COLOR. SHE EXPERIENCED TINGLING SENSATION ON HER FINGERS FOR BOTH HANDS. SHE RINSED BOTH HANDS WITH RUNNING WATER, AND IT WAS REPORTED SYMPTOMS DISAPPEARED AT A LATER TIME. NO MEDICAL ATTENTION OR TREATMENT WAS RECEIVED FOR THE H2O2 SKIN REACTION AND IT WAS REPORTED SHE RECOVERED. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Skin Burning Sensation

  MAUDE report 12844583 ↗
• MalfunctionOct 15, 2021Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) RECEIVED A "CHEMICAL BURN" OR SKIN REACTION WHEN REMOVING TWO STERILIZATION LOADS FROM A STERRAD® 100NX UNIT AND HANDLING A NEW STERRAD® 100NX CASSETTE. THE HCW WAS NOT WEARING GLOVES, AND IT IS UNCLEAR IF THE HYDROGEN PEROXIDE SKIN REACTION WAS RELATED TO HANDLING THE TWO STERILIZATION LOADS OR FROM THE NEW CASSETTE, BUT SHE DEVELOPED WHITE ¿PATCHES¿ AND FELT A STINGING SENSATION ON HER HANDS. SHE WASHED HER HANDS AND REPORTED ¿IT WAS A LOT BETTER.¿ THE SKIN REACTION ON HER HANDS/PALMS LASTED ONE DAY, AND SHE DID NOT RECEIVE MEDICAL TREATMENT. LASTLY, IT WAS NOTED HER STATUS WAS ¿GOOD.¿ THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Skin Burning Sensation

  MAUDE report 12640114 ↗
• MalfunctionAug 26, 2021Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) RECEIVED A "BURN" OR SKIN REACTION WHEN REMOVING A STERRAD® 100NX CASSETTE FROM THE COLLECTION BOX. THE HCW WAS NOT WEARING GLOVES AND SHE MADE CONTACT WITH HYDROGEN PEROXIDE ON HER INDEX FINGER. SHE WASHED WITH RUNNING WATER AND TREATED THE SKIN REACTION WITH GENTAMICIN OINTMENT BY HER OWN SELF-JUDGMENT. SHE DID NOT RECEIVE MEDICAL TREATMENT, NOR WAS SHE DIAGNOSED BY A PHYSICIAN. THE SKIN REACTION MEASURED 2 CM AND SYMPTOMS RESOLVED THE FOLLOWING DAY. LASTLY, IT WAS NOTED HER STATUS WAS ¿COMPLETELY RECOVERED.¿ THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Skin Burning Sensation

  MAUDE report 12375000 ↗
• MalfunctionApr 15, 2021Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED A HEALTHCARE WORKER (HCW) RECEIVED A SKIN REACTION WHILE OPENING THE PACKAGING OF A STERRAD® 100NX CASSETTE AND NOTICED LIQUID ON THE CASSETTE. THE HEALTHCARE WORKER WAS NOT WEARING GLOVES. THE SYMPTOMS INCLUDED WHITE SPOTS ON BOTH HANDS AND THE HCW IMMEDIATELY WASHED THEM WITH WATER. THE SYMPTOMS LASTED APPROXIMATELY FOUR AND A HALF HOURS. THE HCW DID NOT SEEK OR RECEIVE ANY MEDICAL ATTENTION/TREATMENT AND IS REPORTED TO BE "OKAY." THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Skin Discoloration

  MAUDE report 11676154 ↗
• MalfunctionJan 13, 2021Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED TWO HEALTHCARE WORKERS (HCWS) EXPERIENCED A BURN AFTER TOUCHING A STERRAD 100NX CASSETTE WHICH HAD BEEN MISTAKENLY INSERTED INTO A STERRAD NX STERILIZER. THE HCWS WERE NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (GLOVES) AT THE TIME OF THE EVENT AND DID NOT RECEIVE ANY MEDICAL ATTENTION/TREATMENT. NO STEPS WERE TAKEN TO RESOLVE OR TREAT THE SKIN REACTION, THE SYMPTOMS DISAPPEARED THE SAME DAY, AND THE HCWS ARE NOW RECOVERED. THIS IS TWO OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBER 2084725-2021-00006 FOR THE FIRST HCW. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Burning Sensation; Skin Irritation

  MAUDE report 11168426 ↗
• MalfunctionJan 13, 2021Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED TWO HEALTHCARE WORKERS (HCWS) EXPERIENCED A BURN AFTER TOUCHING A STERRAD 100NX CASSETTE WHICH HAD BEEN MISTAKENLY INSERTED INTO A STERRAD NX STERILIZER. THE HCWS WERE NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (GLOVES) AT THE TIME OF THE EVENT AND DID NOT RECEIVE ANY MEDICAL ATTENTION/TREATMENT. NO STEPS WERE TAKEN TO RESOLVE OR TREAT THE SKIN REACTION, THE SYMPTOMS DISAPPEARED THE SAME DAY, AND THE HCWS ARE NOW RECOVERED. THIS IS ONE OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS 2084725-2021-00007 FOR THE SECOND HCW. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY.

  Patient problems: Burning Sensation; Skin Irritation

  MAUDE report 11168425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071385, K092622, K111377, K160903, K212174, K234082. One submission often covers many models, so check the product and lot details in each record.

• Z-0846-2015 · Nov 4, 2014 · Terminated
  STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and m
• Z-0402-2014 · Nov 11, 2013 · Terminated
  STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical
• Z-0044-2014 · Sep 18, 2013 · Terminated
  STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
• Z-2174-2013 · Jul 25, 2013 · Terminated
  STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusabl
• Z-1026-2013 · Mar 22, 2013 · Terminated
  STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX p
• Z-1632-2008 · Feb 25, 2008 · Terminated
  STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.