Transpac™ 46106-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709050914), received between May 7, 2025 and May 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 7, 2025No Flow; No Flow

  THE EVENT INVOLVED ATRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH AND MACRODRIP WHERE THE CUSTOMER REPORTED THAT THEIR NICU HAS BEEN EXPERIENCING ISSUES WITH ARTERIAL LINE OCCLUSION ALARMS ON THEIR BD ALARIS PUMPS WHEN USING THE TRANSPAC KIT. THE INFUSION RATE IS TYPICALLY SET AT 1 ML/HR. THE CUSTOMER STATED THAT THEIR TROUBLESHOOTING HAS BEEN UNSUCCESSFUL THE MAJORITY OF THE TIME AND THEY'VE ONLY BEEN SUCCESSFUL CORRECTING THE ISSUE WHEN THE CAPS ARE CHANGED ON THE TRANSPAC. THE MAJORITY OF THE TIME IT IS NOT SUCCESSFUL, AND THEY HAVE TO CHANGE OUT THE SET. THE INCIDENT OCCURRED DURING PATIENT USE; NO MEDICATION WAS BEING USED WITH THE DEVICE. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980302 ↗

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