FDA Recall Terminated

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.

Recall: Z-0991-2007 · Initiated May 16, 2007

Recall

Recall Number
Z-0991-2007
Event Number
37968
Firm
Smiths Medical PM, Inc.
FEI Number
2183502
Product Code
BTL
Status
Terminated
Root Cause
Other
Initiated
May 16, 2007
Posted
July 4, 2007
Terminated
October 10, 2008
Address
N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

Description

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.

Reason

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.

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.

Distribution

Nationwide.

Quantity

93