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.
FDA Recall Z-0991-2007 · Posted 2007-07-04
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Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeBTL
Date Initiated2007-05-16
Date Terminated2008-10-10
Product Quantity93
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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