McKesson 37-6240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00612479199545), received between Jan 9, 2024 and Aug 28, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Contamination; Contamination

  DESCRIPTION OF EMAIL RECEIVED FROM COMPLAINT: (B)(6) UTILIZED MCKESSON'S NORMAL SALINE ISOTONIC IRRIGATION SOLUTION ON A LYMPHEDEMA WOUND IN (B)(6) 2024. (B)(6) WOUND BECAME INFECTED AND SHE WAS ULTIMATELY DIAGNOSED WITH A VIBRIO VULNIFICUS BACTERIAL INFECTION. (B)(6) CLAIMS THAT AS A DIRECT AND PROXIMATE RESULT OF CONTAMINATED PRODUCT SHE WAS PLACED WITH A PERIPHERALLY INSERTED CENTRAL CATHETER FOR MULTIPLE ANTIBIOTIC TREATMENT AND CONTINUES TO RECEIVE FOLLOW UP CARE THEREAFTER.

  Patient problems: Bacterial Infection

  MAUDE report 20091399 ↗
• InjuryJan 9, 2024Contamination; Contamination

  ON 15-DEC-23, NURSE ASSIST RECEIVED A MEDWATCH REPORT VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM MEDWATCH REPORT: MY HUSBAND HAS A SCI (SPINAL CORD INJURY). WE HAVE BEEN USING MCKESSON SALINE MIXED WITH GENTAMICIN AS A BLADDER RINSE TO PREVENT URINARY TRACT INFECTIONS. HE HAD 9 UTI'S IN ONE YEAR, UNEXPLAINED. NOW WE FIND OUT THAT THE SALINE WE WERE USING IS PART OF A RECALL. COULD THAT HAVE ATTRIBUTED TO ALL THE UTI'S THAT HE HAD? I AM GIVING THE DATE OF HIS LAST URINE CULTURE. HE WAS TREATED WITH CIPRO. DATES OF USE: (B) (6) 2016 - (B)(6) 2023. BLADDER RINSE PER UROLOGIST TO PREVENT UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 18475008 ↗

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