McKesson 37-6270Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00612479199576), received between Dec 22, 2023 and May 3, 2024 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Contamination” (3 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.

• InjuryMay 3, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  FROM MEDWATCH REPORT (MW5153041): NURSE ASSIST MANUFACTURED SALINE FOR BLADDER IRRIGATION POTENTIALLY CAUSED AN INCREASE IN URINARY TRACT INFECTIONS IN IMMUNOCOMPROMISED PATIENT. CULTURE RESULTS SHOWED THE FOLLOWING RESULTS: SERRATIA MARCESCENS AND CITROBACTER KOSERI - (B)(6) 2024, CITROBACTER KOSERI - (B)(6) 2024, CITROBACTER KOSERI - (B)(6) 2024, SERRATIA MARCESCENS - (B)(6) 2023, SERRATIA MARCESCENS - (B)(6) 2023 - ALSO ON (B)(6) 2023. BLADDER IRRIGATION, TWICE DAILY. REFERENCE REPORT: MW5153042. FROM MEDWATCH REPORT (MW5153042): NURSE ASSIST MANUFACTURED SALINE FOR BLADDER IRRIGATION POTENTIALLY CAUSED AN INCREASE IN URINARY TRACT INFECTIONS IN IMMUNOCOMPROMISED PATIENT.CULTURE RESULTS SHOWED THE FOLLOWING RESULTS: SERRATIA MARCESCENS AND CITROBACTER KOSERI - (B)(6) 2024, CITROBACTER KOSERI - (B)(6) 2024, CITROBACTER KOSERI - (B)(6) 2024, SERRATIA MARCESCENS - (B)(6) 2023, SERRATIA MARCESCENS - (B)(6) 2023 - ALSO ON (B)(6) 2023. BLADDER IRRIGATION, TWICE DAILY.REFERENCE REPORT: MW5153041.

  Patient problems: Bacterial Infection; Urinary Tract Infection

  MAUDE report 19237438 ↗
• DeathDec 27, 2023Contamination; Contamination

  ON 12-DEC-23, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM FDA MEDWATCH OF THE FOLLOWING EVENT. DESCRIPTION FROM MEDWATCH REPORT: THERE WAS SO MANY TEST DONE ON MY MOTHER, I HAVE ALL OF HER MEDICAL RECORDS. HER ULCER WOUND GOT INFECTED WITH CANDIDA AURIS, WE WOULD WASH THE WOUND DAILY WITH WATER. SHE HAD WHITE SPORES FUNGI GROWTH AROUND THE WOUNDS AND SHE HAD A "CATHETER" AS WELL. THE HOSPITAL SAID THE CANDIDA AURIS GOT INTO HER BLOOD, SHE WENT INTO SEPTIC SHOCK AND DIED. I PURCHASED THE WATER FOR HER. IF I WOULD HAVE KNOWN THERE WAS ANY LIKELY HOOD OF KNOWN "ING", IT WAS NOT STERILE. I WOULD NEVER BROUGHT FOR HER BECAUSE I KNEW WE CANT USE TAP WATER.

  Patient problems: Fungal Infection; Septic Shock

  MAUDE report 18402522 ↗
• InjuryDec 27, 2023Contamination; Contamination

  ON 07-NOV-23, NURSE ASSIST RECEIVED A COMPLAINT VIA E-MAIL FROM CANBIN MA OF THE FOLLOWING EVENT DESCRIPTION FROM E-MAIL: AFTER USING THE 0.9% SODIUM CHLORIDE SOLUTION, I NOTICED A SIGNIFICANT SKIN IRRITATION, WHICH LED TO SWELLING, AS EVIDENCED IN THE ATTACHED IMAGE. THIS IS A CONDITION I HAVE NEVER EXPERIENCED BEFORE, AND IT HAS CAUSED ME SIGNIFICANT DISCOMFORT AND CONCERN. GIVEN THE SEVERITY OF MY REACTION AND THE FACT THAT NO SUCH SYMPTOM HAS EVER OCCURED TO ME PRIOR TO USING THE PRODUCT, I KINDLY REQUEST YOUR ASSISTANCE IN RESOLVING THIS MATTER.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18400825 ↗
• DeathDec 22, 2023Contamination; Contamination

  ON 28-NOV-23, NURSE ASSIST RECEIVED A MEDWATCH REPORT (MW5148357) VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM MEDWATCH REPORT: CDER RECEIVED THE MEDWATCH REPORT. THE REPORTER STATES THE IMPACTED INDIVIDUAL HAD AN ULCER WOUND THAT GOT INFECTED WITH CANDIDA AURIS. THEY WASHED THE WOUND DAILY WITH WATER. THERE WERE WHITE SPORES (FUNGAL GROWTH) AROUND THE WOUNDS. THE HOSPITAL DETERMINED THAT CANDIDA AURIS GOT INTO THE BLOOD STREAM OF THE IMPACTED INDIVIDUAL AND THE INDIVIDUAL WENT INTO SEPTIC SHOCK AND DIED. THE REPORTER STATED THAT THEY HAVE THE MEDICAL RECORDS FOR THE DECEASED INDIVIDUAL. INFECTION LEADING TO DEATH.

  Patient problems: Fungal Infection; Septic Shock

  MAUDE report 18387517 ↗

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