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Class 1 Device Recall BagEasy Resuscitatior |
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Date Initiated by Firm |
June 22, 2010 |
Date Posted |
September 08, 2010 |
Recall Status1 |
Terminated 3 on March 22, 2011 |
Recall Number |
Z-2333-2010 |
Recall Event ID |
56162 |
510(K)Number |
K934310 K940581
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Product Classification |
Ventilator, emergency, manual (resuscitator) - Product Code BTM
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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 Child/Infant product: K940581 Part#: 562080 - Lot#:48719, 49144 Part#: 562081 - Lot#:49643, 49660 Part#: 562082 - Lot#: 48091, 49274, 49386, 49487 Part#: 562084 - Lot#: 48119, 48578, 48733, 48941, 49042, 49254 Part#: 562086 - Lot#: 47895, 48071, 48488, 48823 Part#: 562110 - Lot#: 49489 Part#: 562111 - Lot#: 49611, 48276 Part#: 32628- Lot#: 49273, 49273, 47834 Part#: 32629 - Lot#: 48140, 48141, 48428, 48142, 48275, 48652, 48429 |
Recalling Firm/ Manufacturer |
Westmed Inc 5580 South Nogales Hwy Ste 170 Tucson AZ 85706
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For Additional Information Contact |
Michelle Wates 520-294-7987 Ext. 1233
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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.
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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 |
2,734 |
Distribution |
Worldwide distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = BTM and Original Applicant = RESPIRONICS, INC.
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