Ventlab Resuscitator Bag Recall Gets Class I Status

Ventlab LLC is recalling manual resuscitator bags because a duckbill valve may stick and prevent air from getting to the patient, the FDA and the company announced.

One injury has been reported due to a stuck valve, which can prevent oxygen from reaching tissues--slowing breathing and even leading to death. The company received 31 reports of a delay in oxygenation.The Class I-level recall affects devices that were manufactured and distributed from January 10, 2013 through July 1, 2013 and are made for medical personnel use only.The trade names for the recalled bags include Airflow Bag, Breath Tech Bag, Provider Bag, STAT-Check Bag, Safe Spot Bag, V-Care Bag, Medline Bag, RescuMed Bag, VT1000 Kit.Grand Rapids, MI-based Ventlab is voluntarily recalling the bags. The sticking may be the result of inadequate curing in the manufacturing process, it said.More information about the recall is available on the FDA's website.

Nancy Crotti is a contributor to Qmed and MPMN.

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