Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory res
FDA device recall Z-0991-2007 · posted 2007-07-04 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTL
- Quantity affected
- 93
- Distribution
- Nationwide.
- Date initiated
- 2007-05-16
- Date posted
- 2007-07-04
- Date terminated
- 2008-10-10
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS (K051322) | Smiths Medical International , Ltd. | 2005-08-05 |