FDA Medical Device Recalls (openFDA)
Smiths Medical PM, Inc.: 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 number
- Z-0991-2007
- Recalling firm
- Smiths Medical PM, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2007-05-16
- Posted
- 2007-07-04
- Terminated
- 2008-10-10
- 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.
- Root cause
- 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
- 93
- Distribution
- Nationwide.
- Lot, serial or model codes
- 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,
- 510(k) numbers
- ["K051322"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 2183502
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28