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U.S. Department of Health and Human Services

Class 2 Device Recall Pneupac VR1

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  Class 2 Device Recall Pneupac VR1 see related information
Date Initiated by Firm May 16, 2007
Date Posted July 04, 2007
Recall Status1 Terminated 3 on October 10, 2008
Recall Number Z-0991-2007
Recall Event ID 37968
510(K)Number K051322  
Product Classification ventilator resuscitator - Product Code BTL
Product Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and inter- hospital transport.
Code Information serial number: 06-12-223, 06-12-225, 06-12-226, 06-12-227, 06-12-228, 06-12-247, 06-12-248, 06-12-249, 06-12-250, 06-12-251, 06-12-252, 06-12-253, 06-12-254, 06-12-255,   07-01-159, 0701-160, 07-01-161, 07-01-162, 07-01-163, 07-01-164, 07-01-165, 07-01-166, 07-01-167, 07-01-169, 07-01-170, 07-01-171, 07-01-187, 07-01-188, 07-01-189, 07-01-190, 07-01-191, 07-01-194, 07-01-195, 07-01-196, 07-01-197, 07-01-198, 07-01-199, 07-01-217, 07-01-218, 07-01-219, 07-01-220, 07-01-221, 07-01-222, 07-01-223, 07-01-224, 07-01-225, 07-01-226, 07-01-227, 07-01-228, 07-01-229, 07-01-230, 07-01-231, 07-01-232, 07-01-233, 07-01-234, 07-01-250, 07-01-251, 07-01-252, 07-01-253, 07-01-254, 07-01-255, 07-01-256, 07-01-257, 07-01-258, 07-01269, 07-01-207, 07-01-271, 07-01-272, 07-01-273, 07-01-274, 07-01-275, 07-01-276, 07-01-277, 07-01-421, 07-01-422, 07-01-423, 07-01-424, 07-01-428, 07-01-430, 07-01-431, 07-01-426, 07-01-427, 07-02-321, 07-02-324, 07-02-325, 07-02-326, 07-02-350, 07-02-351, 07-02-352, 07-02-358, 07-04-126,   07-01-200, 07-02-269,
Recalling Firm/
Manufacturer
Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha WI 53186-1856
Manufacturer Reason
for Recall
Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.
FDA Determined
Cause 2
Other
Action Distriblutors and end users were contacted by phone (May 10 - May 24, 2007) and end users were additionally sent a Safety Action Bulletin May 21, 2007. The Bulletin was used as a script.
Quantity in Commerce 93
Distribution Nationwide.
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 = BTL and Original Applicant = SMITHS MEDICAL INTERNATIONAL, LTD.
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