Transpac™ 46112-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709061781), received between Jun 11, 2025 and Jun 11, 2025 — classified as 1 malfunction.

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

• MalfunctionJun 11, 2025Crack; Crack

  IT WAS REPORTED THAT WITH REGARDS TO A TRANSPAC® IV MONITORING KIT, 60", 03 ML SQUEEZE FLUSH DEVICE, 2 3 WAY STOPCOCKS AND MACRODRIP THAT THE SPIKE BROKE AT THE SET RIGHT AT THE BAG. THE REGISTERED NURSE WAS RELEASING PRESSURE ON THE IV FLUID/PRESSURE BAG TO CHANGE THE IV FLUID BAG WHEN SHE RECOGNIZED THAT THE SPIKE HAD SNAPPED OFF AND WAS INSIDE THE IV FLUID BAG. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184143 ↗

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