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.
This recall has been terminated (originally issued September 8, 2010).
- Company
- Westmed Inc
- Recall Initiated
- June 22, 2010
- Posted
- September 8, 2010
- Terminated
- March 22, 2011
- Recall Number
- Z-2332-2010
- Quantity
- 22145
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution.
Lot / Code Info
510K # for Adult product: K934310 Part Number: 562013: Lot #47952, 48174, 48320, 48489, 48718, 48893, 49093, 49179, 49353, 49567, 49685 Part Number: 562048: Lot#47772, 47896, 47971, 47972, 48319, 48449, 48577, 48892, 48970, 49092, 49178 Part Number: 562133: Lot# 48321, 49225 49407 Part Number: 562136: Lot#47728, 49094 49275
Root Cause
Nonconforming Material/Component
Action Taken
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.