McKesson 6049Recalls & reported problems
Mckesson Medical-Surgical Inc. · IV CATH 23X3/4 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10612479212593), received between Jul 11, 2025 and May 11, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 reports).
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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Leak/Splash
CUSTOMER REPORTED LEAKAGE OF MEDICATION FROM THE IV CATHETER DURING FLUSHING AT THE INJECTION SITE. THE EVENT DATE WAS REPORTED AS (B)(6) 2026. NO PATIENT INJURY OR DEATH WAS REPORTED. SAMPLES WERE DISCARDED BY THE CUSTOMER AND THE LOT NUMBER WAS UNAVAILABLE. THE MANUFACTURER CONDUCTED AN INVESTIGATION BASED ON THE MOST RECENTLY PRODUCED LOT AND NO ABNORMALITIES WERE IDENTIFIED IN THE DHR REVIEW. THE MANUFACTURER DETERMINED THAT IMPROPER ASSEMBLY BETWEEN THE WEDGE AND TUBE MAY CAUSE LEAKAGE DEFECTS. PREVIOUSLY, THE VISION INSPECTION SYSTEM INSPECTED ONLY ONE SIDE OF THE ASSEMBLY USING A SINGLE CAMERA, WHICH COULD RESULT IN UNDETECTED DEFECTS IN BLIND SPOTS. CORRECTIVE ACTION WAS IMPLEMENTED BY INSTALLING AN ADDITIONAL CAMERA ON THE OPPOSITE SIDE TO ENABLE FULL 360-DEGREE INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134125 ↗MalfunctionOct 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT CATHETERS LEAK FROM THE HUB. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THE PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322805 ↗OtherSep 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT AFTER ACCESSING THE PATIENT AND FLUSHING THE CATHETER, LEAKAGE OCCURS FROM THE BASE OF THE HUB. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THE PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977231 ↗MalfunctionAug 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT CATHETERS LEAK FROM THE HUB. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THE PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715048 ↗MalfunctionJul 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT ON 5 OCCASIONS, CATHETERS LEAKED. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THE PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478906 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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