Transpac™ 46109-86Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709050945), received between Sep 3, 2020 and Sep 3, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 3, 2020Material Separation; Material Separation

  THE EVENT INVOLVED A SINGLE LINE TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS VALVE AND 10 CC CONTAMINATION SHEATH SYRINGE THAT THE CUSTOMER REPORTED THE TUBING PULLED OUT OF THE SAMPLING VALVE DURING SET UP. THE NURSE WAS MADE AWARE DURING THE PRIMING PROCESS. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT, NO PATIENT HARM, AND NO REPORT OF DELAY IN THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 10487791 ↗
• MalfunctionSep 3, 2020Material Separation; Material Separation

  THE EVENT INVOLVED A SINGLE LINE TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS VALVE AND 10 CC CONTAMINATION SHEATH SYRINGE THAT THE CUSTOMER REPORTED THE TUBING PULLED OUT OF THE SAMPLING VALVE DURING SET UP. THE NURSE WAS MADE AWARE DURING THE PRIMING PROCESS. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT, NO PATIENT HARM, AND NO REPORT OF DELAY IN THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 10487789 ↗

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