Primary Sets B912601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887787009306), received between Nov 15, 2023 and Jun 17, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K142367); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEH, AND IT WAS REPORTED THAT THE ANTI-REFLUX VALVE IS PERMEABLE, SO NOT FUNCTIONAL. THE INJECTED MEDICATION RISES IN THE SOLUTION AND IS NOT PROPERLY ADMINISTERED TO THE PATIENT. INADEQUATE DOSAGE FOR THE ADMINISTRATION OF MEDICATION, WHICH CAN HAVE HARMFUL CONSEQUENCES FOR THE PATIENT. THERE WERE NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25530948 ↗
• MalfunctionDec 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP. THE REPORTED STATED THAT THE TUBING OF THE DEVICE WAS LEAKING. THERE WAS NO HUMAN HARM REPORTED AS A RESULT OF THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314955 ↗
• MalfunctionNov 15, 2023Backflow; Backflow

  THE EVENT INVOLVED A PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP . IT WAS REPORTED A SYRINGE PUMP TUBING WAS CONNECTED TO THE PROXIMAL SITE, WITH PROPOFOL BEING INFUSION. PROPOFOL IMMEDIATELY MOVED UP TO THE SOLUTE. THE TUBING WAS CLAMPED TO MAKE SURE THE MEDICATION WENT TO THE PATIENT. ONCE THE PATIENT WAS INDUCED, INJECTED THE ANTIBIOTIC VIA THE DISTAL SITE, AND THE SAME PROBLEM OCCURRED, I.E. A RETURN TO THE SOLUTE. THE PRIMARY SOLUTE WAS CONNECTED TO A PERIPHERAL PERMEABLE 20 G CHANNEL. HE ADDED THAT THE PROBLEM WAS NOT REPEATED WITH SUBSEQUENT INJECTIONS AND THE CONTINUOUS INFUSION OF PROPOFOL DID NOT FLOW BACK TO THE SOLUTE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142367. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers