ICU Medical 42800-37Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709098091), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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.

• MalfunctionApr 14, 2023Material Integrity Problem; Material Integrity Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML FLUSH DEVICES, MACRO DRIP POLE MOUNT. THE REPORTER STATED WHEN USING DEVICE THEY WERE UNABLE TO REMOVE THE MONITORING CORD AND IT BREAKS OFF WHEN THEY PUSH THE SMALL CLIP DOWN. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743937 ↗

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