Transpac™ 46112-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709062085), received between Sep 7, 2017 and Sep 7, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 7, 2017Material Separation; Material Separation

  COMPLAINT RECEIVED REGARDING TWO 46112-05, REPORT STATES: THE PRESSURE TUBING ON THIS TRIPLE TRANSDUCER KIT PULLED LOOSE FROM THE LUER. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848052 ↗
• MalfunctionSep 7, 2017Material Separation; Material Separation

  COMPLAINT RECEIVED REGARDING TWO 46112-05, REPORT STATE: THE PRESSURE TUBING ON THIS TRIPLE TRANSDUCER KIT PULLED LOOSE FROM THE LUER. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848050 ↗

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