ICU Medical 42800-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709098169), received between Nov 16, 2022 and Dec 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Disconnection; Disconnection

  THE EVENT INVOLVED A TRANSPAC IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRINGE AND NEEDLELESS VALVE WHERE THE REPORTED STATED THAT THE EXTENSION THAT CONNECTS THE TRANSDUCER SET TO THE INFUSION SET BECAME DISCONNECTED DURING PATIENT USE. THE DEVICE WAS USED WITH NORMAL SALINE. THE SET UP WAS TRANSDUCER TO ALARIS TUBING. THERE WAS A PATIENT INVOLVEMENT AND DELAY IN THERAPY, BUT NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974283 ↗
• MalfunctionNov 16, 2022Disconnection; Material Separation; Disconnection; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRINGE AND NEEDLELESS VALVE. THE REPORTER STATED THAT A PICU/NICU EXPERIENCED A DISCONNECT OF THE INTRAVENOUS (IV) ADMINISTRATION EXTENSION SET AT THE BONDING POINT ON THEIR TRANSPAC IT TRANSDUCER. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15805717 ↗

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