Recall Z-0991-2007
Smiths Medical PM, Inc. · initiated May 16, 2007
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.
Codes / lots: 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,
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: Other
Action taken
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.
Details
- Recall number
- Z-0991-2007
- Initiated
- May 16, 2007
- Posted by FDA
- July 4, 2007
- Terminated
- October 10, 2008
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Quantity
- 93
- Distribution
- Nationwide.
- Recalling firm
- Smiths Medical PM, Inc., Waukesha, WI