Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1195-2023 — MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

U.S. FDA — Device Enforcement · United States · 2023-02-10 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1195-2023
Date of alert
2023-02-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Unetixs Vascular, Inc.
Product category
device
Product type
Devices
Reported risk: The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.