ICU Medical 42801-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709120792), received between Nov 1, 2024 and Nov 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionNov 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLE PORTS, 3ML FLUSH DEVICES, UN-BONDED MACRODRIP (POLE MOUNT) WAS FOUND TO HAVE A BROKEN CONNECTOR LEADING TO A LEAK DURING PATIENT USE. THE REPORTER STATED THAT PATIENTS BLEEDING OUT ARTERIAL LINES. THE EVENT DATE STARTED ON 24-MAY-2024 UP UNTIL 02-OCT-2024. NO CONVERSION FROM ANOTHER SUPPLIER, THE SAME PRODUCT HAS BEEN USED FOR A LONG TIME. THE RISK CONCERN IS THE PATIENT SAFETY CONCERN. A SAMPLE PHOTO WAS PROVIDED SHOWING PRODUCTS AFFECTED INSIDE A CLEAR PLASTIC CONTAINER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588177 ↗

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