Medline Industries, Inc. DYNJ42023CRecalls & reported problems
Medline Industries, Inc. · CATH LAB PACK WEST · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889942888443), received between Mar 25, 2024 and Mar 25, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Exposure to Body Fluids1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ON 02/26/2024 THE LINE WAS BEING FLUSHED AFTER POWER INJECTION WHEN THE SYRINGE "CRACKED" CAUSING "BLOOD TO SPLASH ON THE MD'S FACE AND EYES".
Patient problems: Exposure to Body Fluids
MAUDE report 18975597 ↗MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ON (B)(6) 2024 WHEN "PULLING BACK BLOOD INTO SYRINGE, IT STREAMED BLOOD ACROSS THE ROOM".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18975544 ↗MalfunctionMar 25, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT ON 02/15/2024 SALINE WAS LEAKING FROM THE SIDE OF THE SYRINGE PRIOR TO A PROCEDURE WHILE "FLUSHING CATHETERS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18974986 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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