ICU Medical 42800-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709098008), received between Mar 30, 2020 and Mar 30, 2020 — classified as 2 malfunctions.

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

• MalfunctionMar 30, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH, #: 302260000-2020-8003, WAS RECEIVED ON MAY 19, 2020.

  Patient problems: Blood Loss

  MAUDE report 9898148 ↗
• MalfunctionMar 30, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A USER FACILITY MANDATORY MEDWATCH, #(B)(4), WAS RECEIVED ON MAY 19, 2020.

  Patient problems: Blood Loss

  MAUDE report 9898144 ↗

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