NAMIC 60230373Recalls & reported problems
Medline Industries, Inc. · MTS-4V MANIFOLD KIT-WEST HILLS HOSP-PG · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489053043), received between Apr 15, 2024 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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.
Reports received per month
Recalls naming this device
- Mar 24, 2026Open, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2145-2026 · Root cause: Under Investigation by firm · FDA record ↗
- Feb 27, 2026Open, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1718-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Connection Problem1
- Fluid/Blood Leak1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944426 ↗MalfunctionApr 15, 2024Connection Problem; Connection Problem
ACCORDING TO THE CUSTOMER, "THE MANIFOLD SYRINGE SPINS ON ITS OWN AND DISENGAGES".
Patient problems: Insufficient Information
MAUDE report 19111733 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.