ICU Medical 42800-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709098053), received between Jan 25, 2023 and Jan 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (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.

• MalfunctionJan 25, 2023Separation Problem; Separation Problem

  THE EVENT INVOLVED A TRANSPAC IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRINGE AND NEEDLELESS VALVE WHERE IT WAS REPORTED THERE WAS A SEPARATION IN THE TUBING. THE REPORTER STATED WHEN DOING ROUNDS AT 0900 A SMALL AMOUNT OF BLOOD WAS NOTICED BACKING UP IN THE UMBILICAL ARTERIAL CATHETER (UAC). THE LINE WAS FLUSHED AND THE CONNECTIONS WERE CHECKED TO SEE IF ANYTHING WAS LOOSE. THE REPORTER STATED BLOOD STARTED BACKING UP EVEN FASTER AND SMALL AMOUNTS OF BLOOD LEAKED ONTO THE MATTRESS. THE LINE WAS TURNED OFF TO THE BABY AND IT WAS FOUND THAT THE INTRAVENOUS (IV) TUBING GOING INTO THE BLUE PART OF THE TRANSDUCER HAD COME APART. THE UAC WAS REMOVED WITHOUT INCIDENT AND A HEMATOCRIT AND HEMOGLOBIN WAS DRAWN AFTER THE INCIDENT WITH NO LOWERING OF THE HEMOGLOBIN. THERE WAS PATIENT INVOLVMENT, HOWEVER NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244836 ↗

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