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

Recall Z-1684-2023 — AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

U.S. FDA — Device Enforcement · United States · 2023-04-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1684-2023
Date of alert
2023-04-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Avanos Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30181360
Reported risk: Some of the ambIT kits were potentially distributed without an air in-line filter.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.