Recall Z-2332-2010 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Westmed Inc
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
| Date | Sep 8, 2010 (initiated Jun 22, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 1-80 |
| Quantity | 22145 |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |