SteriCare Solutions 6281Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850421008846), received between Dec 27, 2023 and Jan 9, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Contamination” (4 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 6, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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: MY SON, WHO IS IMMUNOCOMPROMISED, WAS SEEN BY HIS PODIATRIST FOR AN INGROWN TOE NAIL. A PORTION OF THE NAIL WAS REMOVED AND IT WAS CLEANED WITH STERICARE 0.9% SODIUM CHLORIDE IRRIGATION BATCH NUMBER 6281. THIS HAS BEEN RECALLED DUE TO NOT BEING STERILE. THIS WAS USED ON AN OPEN WOULD/SURGICAL SITE ON MY SON. HE WAS PUT ON AN ANTIBIOTIC TO TRY AND PREVENT INFECTION. A WEEK LATER THE TOE WAS GETTING MUCH WORSE, THE DR AGAIN CLEANED THE WOUND OUT AND USED THIS SAME SOLUTION TO CLEAN IT AND ANOTHER ANTIBIOTIC. IN THE WEEKS THAT FOLLOWED MY SON WAS SEEN BY HIS PEDIATRICIAN AND AS WELL AS AN URGENT CARE. HE WAS ON SEVERAL DIFFERENT ANTIBIOTICS BUT ON (B)(6) HE WAS DOING VERY BAD. WE TOOK HIM TO (B)(6) HOSPITAL WHERE HE WAS ADMITTED TO ICU. HE HAD SEVERAL BACTERIA GROWING IN HIS TOE, HE WAS IN SEPTIC SHOCK AND THE INFECTION HAD SPREAD TO HIS BONE. HE SPENT ALMOST 2 WEEKS IN THE HOSPITAL, BEING ADMITTED TO THE ICU 2 TIMES WHILE THERE. HE NEEDED SEVERAL ANTIBIOTICS, INCLUDING IV ANTIBIOTICS. HE NEEDED MULTIPLE TESTS, XRAYS, AND MRIS. AS WELL AS WEEKS OF ANTIBIOTICS AFTER

  Patient problems: Septic Shock; Unspecified Infection

  MAUDE report 18475026 ↗
• 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: I USED THE NURSE ASSIST LLC STERILE SALINE PRODUCT TO IRRIGATE A SEROMA IN MY ABDOMEN FROM (B)(6) OF 2023. I HAVE SINCE HAD 3 DÉBRIDEMENT SURGERIES TO CLEAR DAMAGED TISSUE FROM MY WOUND. I HAD TWO AS AN OUT PATIENT AND THE MOST RECENT INPATIENT. THEY ONLY DID A CULTURE ON THE MOST RECENT AND IT GREW OUT MRSA (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS). I HAVE BEEN PROGRESSIVELY SICKER SINCE MAY. SIGNIFICANT PHYSICAL DETERIORATION SINCE (B)(6).

  Patient problems: Drug Resistant Bacterial Infection; Unspecified Tissue Injury

  MAUDE report 18475009 ↗
• 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: I HAD TUMMY TUCK SURGERY ON (B)(6) 2023. TO HELP PREVENT INFECTION AND HELP WITH HEALING, MY DOCTOR SUGGESTED TO ORDER THIS PRODUCT. I ORDERED IT FIVE TIMES-APRIL 1, APRIL 10, APRIL 23, MAY 7 AND JULY 23 ALL OF WHICH I HAVE RECEIPTS FOR VIA AMAZON. AFTER SEEING SEPARATION OF MY SCAR ON (B)(6) THAT IS WHEN I ORDERED IT. AFTER USING IT FOR ONLY 3 DAYS, MY INCISION BECAME MORE OPEN AND DISPLAYING SIGNS OF INFECTION. ON (B)(6), IT CAME COMPLETELY OPEN AND, WITH MY DOCTORS RECOMMENDATION, HE STATED TO KEEP USING THE SALINE AND STUFFING IT TO HELP PROMOTE HEALING AND PREVENT INFECTION. I CONTINUED DOING THIS UNTIL (B)(6) WHICH AT THAT TIME, I WENT BACK INTO MY DOCTOR FOR AN INCISION REVISION DUE TO IT HEALED IMPROPERLY DURING THE TIMES I WAS USING THIS PRODUCT.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 18475007 ↗
• InjuryDec 27, 2023Contamination; Contamination

  ON 08-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM (B)(6) OF THE FOLLOWING EVENT DESCRIPTION FROM E-MAIL: I USED THE NURSE ASSIST SODIUM CHLORIDE SOLUTION FOR IRRIGATION, AND I BECAME ILL FOLLOWING THIS USE. PLEASE LET ME KNOW WHICH SPECIFIC CONTAMINANT (IE BACTERIA) WAS FOUND IN THE SOLUTION. MY DOCTOR DIRECTED ME TO GET THIS INFORMATION FROM NURSE ASSIST ASAP SO HE CAN TREAT ME WITH THE CORRECT ANTIBIOTIC. I AM IMMUNE-COMPROMISED AND BECAME ILL FOLLOWING MY USE OF THIS PRODUCT. I KNOW I USED BOTTLES FROM LOT #22124474 AND LOT #23065735. HOWEVER, I HAVE BEEN USING THIS PRODUCT REGULARLY FOR A WHILE, SO I HAVE ALSO USED BOTTLES FROM OTHER LOTS (I NO LONGER HAVE THOSE BOTTLES, AS THEY WERE DISPOSED OF PRIOR TO THE ANNOUNCEMENT OF THE RECALL, SO I CANNOT PROVIDE ADDITIONAL LOT NUMBERS). I DO HAVE RECORDS OF THE PURCHASES IN MY AMAZON ACCOUNT.

  Patient problems: Bacterial Infection; Respiratory Tract Infection

  MAUDE report 18401981 ↗

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