Medical device recalls Moderate risk

Dale Medical Products, Inc. recalls Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 pi…

Recall date
March 24, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1927-2017
FDA classification
Class II
Brand / firm
Dale Medical Products, Inc.
Sold / distributed
Worldwide Distribution -US ( Nationwide) and Internationally to Canada, Costa Rica, Norway, Paraguay, Ireland, Panama, Ecuador, Hong Kong, Malaysia, Italy, UAE, Guatemala, Iceland, Indonesia, and Saudi Arabia.

Why it was recalled

ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation

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