SteriCare Solutions 6240Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00850421008815), received between Dec 4, 2023 and May 4, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K083042); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 6, 2023Class IOpen, Classified

   Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

   Z-0513-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Insufficient Device Problem Information

  ON (B)(6) 2026, NURSE ASSIST RECEIVED A COMPLAINT FROM CARDINAL HEALTH. THE EVENT WAS DESCRIBED AS: "THE COMPLAINT ALLEGES THAT IN (B)(6) 2019, THE PLAINTIFF WAS IMPLANTED WITH A MECHANICAL HEART THAT CONNECTS TO A BATTERY PACK VIA A MEDICAL WIRE THAT REQUIRES ONGOING USE OF WOUND CARE PRODUCTS, INCLUDING STERILE SALINE, TO PREVENT INFECTION. PLAINTIFF ALLEGEDLY PURCHASED WOUND CARE KITS, WHICH INCLUDED THE STERILE SALINE, FROM ORTHODYNAMICS COMPANY, INC. AND THE KITS WERE ALLEGEDLY MANUFACTURED AND/OR SUPPLIED BY CARDINAL HEALTH AND/OR NURSE ASSIST. IN (B)(6) 2023, THE FDA INITIATED A RECALL OF THE STERILE SALINE SOLUTION BECAUSE A DEFECT COULD COMPROMISE THE STERILITY AND ALLOW BACTERIA TO ENTER WITHIN THE KITS/SALINE BOTTLES. ACCORDING TO THE COMPLAINT, THE STERILE SALINE ALLEGEDLY CONTINUED TO BE SOLD AND PLAINTIFF CONTINUED USING IT. ON (B)(6) 2024, PLAINTIFF ALLEGEDLY NOTICED REDNESS AND PAIN AT HER WIRE INSERTION SITE AND DEVELOPED AN INFECTION PURPORTEDLY CAUSED BY THE CONTAMINATED STERILE SALINE. THE INFECTION ALLEGEDLY REMAINS IN HER BLOOD TODAY."

  Patient problems: Unspecified Infection

  MAUDE report 25074637 ↗
• InjuryJun 26, 2024Contamination; Contamination

  COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINTS: I PURCHASED A 48 COUNT, 100ML CASE OF NORMAL SALINE & JUST FOUND OUT IT HAS A RECALL ON IT. WHAT DO I NEED TO DO TO RECTIFY THIS? I HAVE USED 18 BOTTLES FOR BLADDER IRRIGATION AND AM CURRENTLY ON ANTIBIOTICS BECAUSE OF INFECTION THAT I NOW BELIEVE COULD BE DUE TO THE USE OF THIS PRODUCT. I OBVIOUSLY HAVE STOPPED USING IMMEDIATELY.

  Patient problems: Urinary Tract Infection

  MAUDE report 19615058 ↗
• InjuryApr 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  FROM MEDWATCH REPORT (MW5153672). HAD RHINOPLASTY AND SEPTOPLASTY. SALINE USED AFTER PROCEDURE FOR CLEANING. ONE MONTH LATER, ABSCESS WAS PRESENT AND HAD TO HAVE ANOTHER SURGERY TO CLEAR ABSCESS. NOSE IS NOW DEFORMED.

  Patient problems: Deformity/ Disfigurement; Skin Inflammation/ Irritation

  MAUDE report 19201738 ↗
• InjuryApr 9, 2024Contamination; Contamination

  ON 25-MARCH-2024, NURSE ASSIST RECEIVED A MEDWATCH REPORT FROM THE FDA VIA E-MAIL. DESCRIPTION OF EMAIL: REPORTER CALLING, STATING SHE RECEIVED A "DEEP" SERRATIA BACTERIAL INFECTION OF HER HEARTMATE 3 LVAD (LEFT VENTRICULAR ASSIST DEVICE) DRIVELINE AFTER USING RECALLED SALINE. REPORTER STATES ON APPROXIMATELY (B)(6) 2023, SHE INITIALLY NOTICED HER SKIN WAS TURNING RED AROUND HER DRIVELINE. REPORTER STATES THAT AROUND THIS SAME TIME, SHE RECEIVED A LETTER NOTIFICATION THAT THE "NURSE ASSIST" SALINE SUPPLIED TO HER WAS UNDER RECALL. REPORTER STATES SHE STOPPED USING THIS SALINE AND WAS PROVIDED A DIFFERENT PRODUCT, HOWEVER THE REDNESS AROUND HER DRIVELINE SITE PERSISTED, EVENTUALLY TURNING "BRIGHT, TOMATO RED" WHICH RESULTED IN AN EMERGENCY ROOM VISIT ON (B)(6) 2024. REPORTER STATES SHE WAS HOSPITALIZED FOR A SERRATIA BACTERIAL INFECTION, AND HAD TO UNDERGO A "SEVEN-HOUR SURGERY" TO REMOVE INFECTED TISSUE FROM AROUND HER LVAD DRIVELINE, AND THE INFECTION EXTENDED DEEP INTO HER BODY. REPORTER STATES SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024, AND IS CURRENTLY PRESCRIBED ANTIBIOTICS. REPORTER STATES SHE WANTS TO REPORT ABOUT HER PROBLEMS SO THAT OTHERS MAY POSSIBLY AVOID THE T

  Patient problems: Bacterial Infection; Skin Inflammation/ Irritation

  MAUDE report 19069968 ↗
• InjuryJan 29, 2024Contamination; Contamination

  ON (B)(6) 2024, NURSE ASSIST RECEIVED A CALL FROM (B)(6) DESCRIPTION OF CALL: (B)(6) WAS TAKING CARE OF A FAMILY MEMBER WHO HAD A DEEP WOUND THAT REQUIRED A DRAINAGE SINCE MIDDLE OF JUNE. AROUND DECEMBER 30TH THE WOUND STARTED TO SMELL. A VISITING NURSE CAME ON (B)(6) 2024 TO CLEAN THE DEEP WOUND. DURING THE CLEANING, LARGE AMOUNT OF PUS WAS RELEASED. ON (B)(6) 2024, NURSE ASSIST CALLED BACK (B)(6) TO OBTAIN MORE INFORMATION ABOUT THE INCIDENT. DESCRIPTION OF CALL: (B)(6) STATED THAT THEY REUSED THE PRODUCT FOR MULTIPLE CLEANING SESSIONS AND STORED THE PRODUCT IN ROOM TEMPERATURE. THE PRODUCT WAS RECEIVED IN A PLASTIC BAG AND MR. KURPUNSKI DID NOT FIND ANY SIGNS LEAKAGE INSIDE OF THE BAG AFTER VISUALLY INSPECTING IT.

  Patient problems: Unspecified Infection

  MAUDE report 18601519 ↗
• InjuryJan 9, 2024Contamination; Contamination

  ON 13-DEC-23, NURSE ASSIST RECEIVED A MEDWATCH REPORT VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM MEDWATCH REPORT: ORDERED AND USED ON PATIENT BEGINNING IN (B)(6) 2022 DUE TO NATIONWIDE SHORTAGE OF SALINE SOLUTION TO CLEAN PORT (BILIARY) DRAINAGE FROM WOUND SITE. DEVELOPED LIFE-THREATENING MRSA AT THAT SITE SHORTLY IN (B)(6) 2022. ACCORDING TO RECORDS: WOUND CULTURE COLLECTED ON (B)(6) 2022 WITH RESULT FOR POSITIVE MRSA. ON (B)(6) 2022. HOSPITALIZED AT (B)(6) HOSPITAL ON STRONG ANTIBIOTIC (VANCOMYCIN) TREATMENT THEREAFTER.

  Patient problems: Drug Resistant Bacterial Infection; Purulent Discharge

  MAUDE report 18475036 ↗
• InjuryDec 27, 2023Contamination; Contamination

  ON 27-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FROM (B)(6) OF THE FOLLOWING EVENT: DESCRIPTION FROM PHONE CALL WITH (B)(6): HAD AN OPEN WOUND ON HIS BACK SINCE (B)(6) 2022, STARTED RECEIVING HOME HEALTH CARE SINCE (B)(6) 2023. NURSE ORDER MEDICAL SUPPLIES THAT CAME WITH A 6240 SALINE BOTTLE THAT WAS USED TO CLEAN THE OPEN WOUND. THE SUPPLIES ARE DIRECTLY SHIPPED TO (B)(6) HOME. WOUND DID NOT GET BETTER AFTER USING NURSE ASSIST PRODUCT. (B)(6) RECEIVED THE RECALL LETTER AND CALLED TO REPORT AN ADVERSE REACTION. ADVERSE REACTION WAS THAT THE NURSE ASSIST PRODUCT DID NOT HELP WITH TREATING HIS OPEN WOUND ON HIS BACK. IN (B)(6), THE DOCTOR CULTURED THE WOUND AND RESULTS CAME BACK WITH 2 INFECTIONS. DOCTOR PRESCRIBED (B)(6) WITH 2 ANTIBIOTICS, CIPROFLOXACIN AND LINEZOLID, TO TREAT THE INFECTION. DOCTOR CHECKUP ON (B)(6) 2023, WOUND IS GETTING BETTER WITH THE USE OF THE 2 ANTIBIOTICS. 23024895 (2 BOTTLE), 23035031 (2 BOTTLES), 23045346 (2 BOTTLES), 23024921 (1 BOTTLES).

  Patient problems: Bacterial Infection; Skin Infection

  MAUDE report 18402542 ↗
• InjuryDec 27, 2023Contamination; Contamination

  ON 27-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FROM ROBERT HENSL OF THE FOLLOWING EVENT DESCRIPTION FROM PHONE CALL WITH ROBERT HENSL: HAD AN OPEN WOUND ON HIS BACK SINCE (B)(6)2022, STARTED RECEVING HOME HEALTH CARE SINCE (B)(6) 2023. NURSE ORDER MEDICAL SUPPLIES THAT CAME WITH A 6240 SALINE BOTTLE THAT WAS USED TO CLEAN THE OPEN WOUND. THE SUPPLIES ARE DIRECTLY SHIPPED TO RONALD'S HOME. WOUND DID NOT GET BETTER AFTER USING NURSE ASSIST PRODUCT. RONALD RECEIVED THE RECALL LETTER AND CALLED TO REPORT AN ADVERSE REACTION. ADVERSE REACTION WAS THAT THE NURSE ASSIST PRODUCT DID NOT HELP WITH TREATING HIS OPEN WOUND ON HIS BACK. IN NOVEMBER, THE DOCTOR CULTURED THE WOUND AND RESULTS CAME BACK WITH 2 INFECTIONS. DOCTOR PRESCRIBED RONALD WITH 2 ANTIBIOTICS, CIPROFLOXACIN AND LINEZOLID, TO TREAT THE INFECTION. DOCTOR CHECKUP ON (B)(6) 2023, WOUND IS GETTING BETTER WITH THE USE OF THE 2 ANTIBIOTICS. 23024895 (2 BOTTLE), 23035031 (2 BOTTLES), 23045346 (2 BOTTLES), 23024921 (1 BOTTLES).

  Patient problems: Bacterial Infection; Skin Infection

  MAUDE report 18402473 ↗
• InjuryDec 27, 2023Contamination; Contamination

  ON 27-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FROM (B)(6) OF THE FOLLOWING EVENT. DESCRIPTION FROM PHONE CALL WITH (B)(6) : HAD AN OPEN WOUND ON HIS BACK SINCE (B)(6) 2022, STARTED RECEVING HOME HEALTH CARE SINCE 07/17/2023. NURSE ORDER MEDICAL SUPPLIES THAT CAME WITH A 6240 SALINE BOTTLE THAT WAS USED TO CLEAN THE OPEN WOUND. THE SUPPLIES ARE DIRECTLY SHIPPED TO (B)(6) HOME. WOUND DID NOT GET BETTER AFTER USING NURSE ASSIST PRODUCT. (B)(6) RECEIVED THE RECALL LETTER AND CALLED TO REPORT AN ADVERSE REACTION. ADVERSE REACTION WAS THAT THE NURSE ASSIST PRODUCT DID NOT HELP WITH TREATING HIS OPEN WOUND ON HIS BACK. IN NOVEMBER, THE DOCTOR CULTURED THE WOUND AND RESULTS CAME BACK WITH 2 INFECTIONS. DOCTOR PRESCRIBED RONALD WITH 2 ANTIBIOTICS, CIPROFLOXACIN AND LINEZOLID, TO TREAT THE INFECTION. DOCTOR CHECKUP ON (B)(6) 2023, WOUND IS GETTING BETTER WITH THE USE OF THE 2 ANTIBIOTICS. 23024895 (2 BOTTLE), 23035031 (2 BOTTLES), 23045346 (2 BOTTLES), 23024921 (1 BOTTLES).

  Patient problems: Bacterial Infection; Skin Infection

  MAUDE report 18402471 ↗
• InjuryDec 27, 2023Contamination; Contamination

  ON 27-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FROM (B)(6) OF THE FOLLOWING EVENT DESCRIPTION FROM PHONE CALL WITH (B)(6) : HAD AN OPEN WOUND ON HIS BACK SINCE (B)(6) 2022, STARTED RECEVING HOME HEALTH CARE SINCE (B)(6) 2023. NURSE ORDER MEDICAL SUPPLIES THAT CAME WITH A 6240 SALINE BOTTLE THAT WAS USED TO CLEAN THE OPEN WOUND. THE SUPPLIES ARE DIRECTLY SHIPPED TO RONALD'S HOME. WOUND DID NOT GET BETTER AFTER USING NURSE ASSIST PRODUCT. (B)(6) RECEIVED THE RECALL LETTER AND CALLED TO REPORT AN ADVERSE REACTION. ADVERSE REACTION WAS THAT THE NURSE ASSIST PRODUCT DID NOT HELP WITH TREATING HIS OPEN WOUND ON HIS BACK. IN NOVEMBER, THE DOCTOR CULTURED THE WOUND AND RESULTS CAME BACK WITH 2 INFECTIONS. DOCTOR PRESCRIBED RONALD WITH 2 ANTIBIOTICS, CIPROFLOXACIN AND LINEZOLID, TO TREAT THE INFECTION. DOCTOR CHECKUP ON (B)(6) 2023, WOUND IS GETTING BETTER WITH THE USE OF THE 2 ANTIBIOTICS. 23024895 (2 BOTTLE), 23035031 (2 BOTTLES), 23045346 (2 BOTTLES), 23024921 (1 BOTTLES).

  Patient problems: Bacterial Infection; Skin Infection

  MAUDE report 18402467 ↗
• InjuryDec 27, 2023Contamination; Contamination

  ON 09-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FROM (B)(6) OF THE FOLLOWING EVENT: DESCRIPTION FROM NURSE ASSIST CUSTOMER SERVICE E-MAIL: THIS LADY HAD BREAST SURGERY AND USED THE 6240. SHE USED IT TO CLEAN THE SURGICAL WOUND. SHE ENDED UP IN THE HOSPITAL WITH SEPSIS AND IT WAS TERRIBLE. SHE THINKS IT WAS BECAUSE OF USING THE 6240.

  Patient problems: Sepsis

  MAUDE report 18402253 ↗
• MalfunctionDec 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  ON 4-JUL-2023, CUSTOMER NOTIFIED NURSE ASSIST VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM A CUSTOMER: (TRANSLATED) IS RUST INSIDE THE TRAY, IT APPEARS TO BE NACL LEAKING FROM THE BOTTLE AS IT IS ALMOST EMPTY. THIS IS THE THIRD KIT THAT CONTAINS RUST AND IS NOT USABLE. I'LL LET YOU KNOW IF THERE ARE ANY OTHERS. PHOTOS OF THE KIT IN QUESTION ARE ATTACHED. THESE BOTTLES WERE REPORTED BY THE INITIAL REPORTER AS LEAKING PRIOR TO USE ON A PATIENT. THERE WAS NO REPORT OF ANY PATIENT IMPACT OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255616 ↗
• MalfunctionDec 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  ON 17-NOV-2022, CUSTOMER NOTIFIED NURSE ASSIST VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM A THIRD-PARTY CUSTOMER: RECEIVED BOTTLES OF 6240 THAT WERE LEAKING. THERE WAS NO SHIPPING DAMAGE. THESE BOTTLES WERE REPORTED BY THE INITIAL REPORTER AS LEAKING PRIOR TO USE ON A PATIENT. THERE WAS NO REPORT OF ANY PATIENT IMPACT OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255593 ↗
• MalfunctionDec 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  ON (B)(6) 2022, CUSTOMER NOTIFIED NURSE ASSIST VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM CUSTOMER: RECEIVED 5,472 BOTTLES OF 6240 THAT HAD FLASHING ON CAPS AND WERE LEAKING. THESE BOTTLES WERE REPORTED BY THE INITIAL REPORTER AS LEAKING PRIOR TO USE ON A PATIENT. THERE WAS NO REPORT OF ANY PATIENT IMPACT OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18255579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083042. One submission often covers many models, so check the product and lot details in each record.

• Z-0511-2024 · Nov 6, 2023 · Open, Classified
  0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV