ICU Medical 42801-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709120662), received between Nov 22, 2021 and Nov 22, 2021 — 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.

• MalfunctionNov 22, 2021Disconnection; Disconnection

  THE EVENT INVOLVED A TRANSPAC IT MONITORING KIT, 72" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MACRODRIP AND OCCURRED AT 12:00 PM THAT THE CUSTOMER REPORTED WHEN PLACING THE PRIMING PRESSURE TUBING IN REACH OF THE PROVIDER SO THAT IT COULD BE CONNECTED TO THE ARTERIAL CATHETER, THE TUBING'S LAST 14 INCH END PIECE FELL OFF ONTO THE FLOOR. THE EVENT OCCURRED DURING PRIMING, WAS IN USE FOR 5 MINUTES, AND SOMEONE BECAME AWARE OF THE ISSUE THROUGH DIRECT VISUALIZATION. IT IS REPORTED THAT THIS IS NOT A BONDING ISSUE AND THE MALE/FEMALE PART IS NOT BONDED, BUT THIS INVOLVES THE MALE CONNECTION PIECE, ITSELF, TO DETACH. ADDITIONALLY, THE CUSTOMER REPORTED THE TUBING¿S END HAS A FEMALE ADAPTER ON THE END AND THE TUBING ATTACHED AT THE MALE CONNECTION IS NOT SUPPOSED TO COME APART AND THAT END HAS A STICKY SUBSTANCE ON IT. NO MEDICATION BEING USED WITH THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857255 ↗

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