ICU Medical 42801-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709120761), received between Aug 14, 2024 and Aug 14, 2024 — classified as 1 malfunction.

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

• MalfunctionAug 14, 2024Disconnection; Disconnection

  THE COMPLAINT/EVENT INVOLVED A SINGLE TRANSPAC® IT MONITORING KIT W/ 104" RED STRIPE TUBING. IT WAS REPORTED THAT THE TUBING DISCONNECTED DOWNSTREAM FROM THE TAP AFTER BLOOD SAMPLING. THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE REPORTED DISCONNECTION. THERE WAS SOME BLOOD LOSS, BUT WITHOUT SERIOUS CLINICAL CONSEQUENCES. THERE WAS NO DELAY IN CRITICAL THERAPY, AND NO NEED OF MEDICAL INTERVENTION. THE TUBING WAS REPLACED WITH A NEW SET FROM THE SAME LIST NUMBER. THERE WAS NO VISIBLE DEFAULT ON THE DEVICE BEFORE USE. NO CUTS, NO TEARS AND NO HOLES WERE OBSERVED ON THE DEVICE. THERE WAS NO REPORT OF HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982411 ↗

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