SteriCare Solutions 6270Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850421008822), received between Jan 9, 2024 and May 16, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Contamination” (5 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 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Contamination; Contamination

  FROM MEDWATCH REPORT (MW5154072): USED NURSE ASSIST STERICARE PART # 6270 250ML STERILE SALINE SOLUTION ON OPEN LEG WOUND BEFORE I WAS NOTIFIED BY AMAZON OF THE RECALL. WOUND HEALING REQUIRED MORE MEDICAL ASSISTANCE THAN INITIALLY PROJECTED. USED THE SALINE TO WASH ON OPEN LEG WOUND 2X/DAY AS DOCTOR.

  Patient problems: Impaired Healing

  MAUDE report 19333447 ↗
• InjuryApr 29, 2024Contamination; Contamination

  ON 16-APR-2024 NURSE ASSIST RECEIVED A COMPLAINT VIA PHONE FOR THE FOLLOWING EVENT. DESCRIPTION FROM NURSE ASSIST CUSTOMER SERVICE: A PERSON CALLED IN AND SAID THAT SHE/HE USED SALINE, AND IT CAUSED HER/HIM TO GET MULTIPLE INFECTIONS. SHE/HIM USED IT TO USED IT IRRIGATE HER/HIS POUCH (BLADDER MADE OUT OF INTESTINES). SHE SAID SHE TOOK ENOUGH TO FILL THE SYRINGE TO IRRIGATE IT ONCE AND THREW AWAY THE REST. SO, SHE DID INJECT IT INTO HER BODY. THE INFECTION CAUSED IT TO COME OUT LIKE COTTAGE CHEESE WHEN SHE/HE IRRIGATED IT (THAT IS WHAT CAME OUT). SHE/HE HAD THREE BOTTLES LEFT BUT THEY ONLY GAVE ME LOT# ON 2. THE 3RD WAS JUST AN EXPIRATION DATE. LOT# 23045430, 22124487, 1/5/25. NAME: (B)(6) # (B)(6). SHE/HE WANTS TO KNOW WHAT BACTERIA IS IN THE PRODUCT SO SHE CAN TELL DOCTOR SO THEY CAN FIGURE OUT HOW TO TREAT IT. NOTHING THEY ARE DOING IS HELPING GET OVER THE INFECTION. THE PERSON HAS THE POUCH FOR 14 YEARS.

  Patient problems: Unspecified Infection

  MAUDE report 19201682 ↗
• InjuryApr 22, 2024Contamination; Contamination

  ON (B)(6) 2024, NURSE ASSIST RECEIVED A LETTER FROM (B)(4) VIA E-MAIL. DESCRIPTION OF E-MAIL:CLAIMANT ALLEGES HE SUFFERED SEVERE INJURY, INCLUDING TOE AMPUTATIONS, DUE TO HIS USE OF NONSTERILE SALINE SOLUTION PURCHASED FROM A THIRD-PARTY SELLER, (B)(4), THROUGH AMAZON.COM. SPECIFICALLY, CLAIMANT CLAIMS THAT HE PURCHASED 0.9% SODIUM CHLORIDE STERILE SALINE 250ML MANUFACTURED BY NURSE ASSIST. HE ALLEGES HE USED THE PRODUCT STARTING IN (B)(6) 2023, UNTIL (B)(6) 2023, WHEN HE NOTICED TOE DISCOLORATION ON HIS LEFT FOOT. HE WAS LATER DIAGNOSED WITH GANGRENE AND UNDERWENT AMPUTATION OF HIS LEFT 2ND AND 3RD TOES. CLAIMANT ALLEGES THE SALINE SOLUTION WAS PART OF A RECALL CAMPAIGN AS A RESULT OF BEING NONSTERILE.

  Patient problems: Bacterial Infection

  MAUDE report 19152619 ↗
• InjuryFeb 20, 2024Contamination; Contamination

  ON 08-FEB-2024, NURSE ASSIST RECEIVED A COMPLAINT FROM MARK BOLTAX VIA PHONECALL. DESCRIPTION OF PHONECALL: MARK BOLTAX STARTED USING 6270 BOTTLES IN JANUARY 2023 ONCE A MONTH TO IRRIGATE HIS FOLEY CATHETER. AFTER INITIAL USE, BOLTAX WOULD DISPOSE THE BOTTLE. BETWEEN THE MONTHS SEPTEMBER 2023 AND DECEMBER 2023, BOLTAX CONTRACTED A UTI. DOCTORS PRESCRIBED HIM MULTIPLE ANTIBIOTICS DUE TO THE PATHOGEN CHANGING.

  Patient problems: Urinary Tract Infection

  MAUDE report 18741786 ↗
• InjuryJan 9, 2024Contamination; Contamination

  ON (B)(6) 2023, NURSE ASSIST RECEIVED A MEDWATCH REPORT VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM MEDWATCH REPORT: USED THE RECALLED PRODUCT TO CLEAN AN OPEN WOUND ON RIGHT FOOT, AND DEVELOPED AN INFECTION WHICH REQUIRED AN ANTIBIOTIC TO RESOLVE ON (B)(6) 2023. OPEN WOUND TO RIGHT FOOT.

  Patient problems: Unspecified Infection

  MAUDE report 18475029 ↗

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