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

Recall Z-0717-2019 — Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿

U.S. FDA — Device Enforcement · United States · 2017-09-05 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0717-2019
Date of alert
2017-09-05
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Product category
device
Product type
Devices
Reported risk: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
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.