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U.S. Department of Health and Human Services

Class 1 Device Recall BagEasy Resuscitatior

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  Class 1 Device Recall BagEasy Resuscitatior see related information
Date Initiated by Firm June 22, 2010
Date Posted September 08, 2010
Recall Status1 Terminated 3 on March 22, 2011
Recall Number Z-2332-2010
Recall Event ID 56162
510(K)Number K934310  K940581  
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
Product 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.
Code Information 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  
Recalling Firm/
Manufacturer		 Westmed Inc
5580 South Nogales Hwy Ste 170
Tucson AZ 85706
For Additional Information Contact Michelle Wates
520-294-7987 Ext. 1233
Manufacturer 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.
FDA Determined
Cause 2		 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 1-800-975-7987 or 1-520-294-7987.
Quantity in Commerce 22145
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTM and Original Applicant = RESPIRONICS, INC.
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