U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
This recall was initiated after westmed, inc. became aware of a potential for disconnection at the patient port retention ring assembly of the bag easy manual resuscitation device.
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The firm, Westmed, sent a letter dated June 21, 2010, to all customers. The letter describes the product, problem and action to be taken by customer. The customers were instructed to cease distribution immediately, notify any facilities that they may have distributed the product identified of the recall, call Customer Service Manager at 1-800-975-7987 x 1223 and/or email kpeterson@westmedinc.com to receive Return Authorization to return identified product, and complete and return the enclosed Bag Easy Recall Reconciliation Checklist.
If you have any question, contact Customer Service at 1-800-975-7987 or 1-520-294-7987.
BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. || A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.