FDAnews Device Daily Bulletin
Quality / Medical Devices / Regulatory Affairs / Postmarket Safety

Ventlab Recalls Resuscitator Bags Over Health Risk

May 20, 2014
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Grand Rapids, Mich.-based Ventlab is recalling a limited number of Ventlab Resuscitator Bags after receiving complaints of a sticking duckbill valve. The problem can prevent air from being delivered to the patient, resulting in hypoxia and hypoventilation

Ventlab said the sticking may be due to incomplete curing during the manufacturing process.

The nationwide, voluntary recall affects 47 series of bags. Users are advised to stop using the bags and immediately contact Ventlab for instructions on how to return them, according to a notice posted on the FDA’s website.

Ventlab said it has received one report of injury requiring medical intervention, due to the malfunction, and 31 reports of delayed air, forcing the patient to use a different device.

The company did not did not return a request for comment as of press time. — Kellen Owings

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