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

Recall Z-0983-2019 — AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

U.S. FDA — Device Enforcement · United States · 2019-01-24 · 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-0983-2019
Date of alert
2019-01-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Maquet Cardiovascular, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
96255605
Reported risk: Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
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.