McKesson 37-6260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00612479199569), received between Jun 19, 2024 and Jun 19, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (1 report).

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Contamination; Contamination

  COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINTS: I PURCHASED CASES OF YOUR STERILE WATER TO FLUSH MY CATHETERS THAT WERE PLACED IN MY URETHRA INTO MY BLADDER FROM (B)(6) 2023 TO APPROXIMATELY (B)(6) 2023. I PURCHASED THE FOLLOWING FROM (B)(6) WHO ALERTED ME OF YOUR SAFETY RECALL: 2 EACH OF STERILE IRRIGATION WATER 250ML 24 BOTTLES ON APRIL 22, 2023 ON ORDER # (B)(6) FOR A TOTAL OF $(B)(6) AND MAY 14, 2023 ON ORDER # (B)(6) FOR A TOTAL OF (B)(6). WE HAVE USED ALL OF THESE 48 BOTTLES. 1 EACH OF MCKESSON STERILE WATER, USP, SINGLE PATIENT USE, NOT FOR INJECTION, 250 ML, 24 COUNT AT (B)(6) ON MAY 30, 2023 ON ORDER # (B)(6) FOR A TOTAL OF $(B)(6). WE HAVE USED 12 OF THESE 24 BOTTLES AND HAVE 12 REMAINING. I HAVE HAD BLADDER AND YEAST INFECTIONS SINCE USING THESE PRODUCTS AND I ALSO HAVE PROSTATE CANCER THAT WAS DISCOVERED AFTER MY BIOPSY ON (B)(6) 2023 THAT WAS THE REASON FOR THE FIRST CATHETER. YOU HAVE STATED TO FDA THAT THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS. I AM NOT CERTAIN OF THAT FACT. I AM IMMUNOCOMPROMISED DUE TO DIABETES AND CANCER.

  Patient problems: Urinary Tract Infection

  MAUDE report 19570719 ↗