Transpac™ 46114-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709075344), received between May 5, 2025 and May 14, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K052828); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND 36" ADMIN SET. LEAKS OF AN UNSPECIFIED FLUID WERE REPORTED IN THE TUBING BETWEEN #1 AND STOPCOCK #2 (FLUID LEAKING OUT) DURING PATIENT USE. THERE WAS NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022467 ↗
• MalfunctionMay 14, 2025Difficult to Flush; Difficult to Flush

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND 36" ADMIN SET. THE LINES REPORTEDLY COULD NOT BE FLUSHED THROUGH DURING USE ON A PATIENT. THERE WAS NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022256 ↗
• MalfunctionMay 14, 2025Leak/Splash; Leak/Splash

  THE COMPLAINT/EVENT INVOLVED A TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND 36" ADMIN SET. LEAKS WERE REPORTED IN THE TUBING OF THE DEVICE DURING USE ON A PATIENT. THE LOCATION OF THE LEAK WAS NEAR THE SMALL HOLE (AND UNSPECIFIED FLUID WAS SHOOTING OUT OF THAT HOLE). THERE WAS NO ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021978 ↗
• MalfunctionMay 5, 2025Crack; Fluid/Blood Leak; Leak/Splash; Crack; Fluid/Blood Leak; Leak/Splash

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV KIT W/35" PT, 6" PT AND 3 NEEDLELESS VALVES. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOTED TO BE CRACKED WITH IV FLUID SPRAYING OUT OF IT. THE DEVICE WAS USED ON A PATIENT, HOWEVER, THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964652 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC® IV KIT W/35" PT, 6" PT AND 3 NEEDLELESS VALVES WHERE THE CUSTOMER REPORTED THAT THE DEVICE HAD IV FLUID SPRAYING OUT OF IT. THE CUSTOMER WAS UNAWARE WHETHER OR NOT THERE WAS A CRACK. THERE WAS PATIENT INVOLVEMENT HOWEVER HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21964550 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06