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U.S. Department of Health and Human Services

Class 2 Device Recall High Frequency Ventilator

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  Class 2 Device Recall High Frequency Ventilator see related information
Date Initiated by Firm April 04, 2005
Date Posted May 23, 2006
Recall Status1 Terminated 3 on November 27, 2007
Recall Number Z-0893-06
Recall Event ID 33938
PMA Number P850064 
Product Classification Ventilator, High Frequency - Product Code LSZ
Product Life Pulse High Frequency Ventilator (HFV)
Code Information Serial numbers 2585 and below.
Recalling Firm/
Manufacturer		 Bunnell, Inc.
436 Lawndale Dr
Salt Lake City UT 84115-2917
For Additional Information Contact
801-467-0811 Ext. 25
Manufacturer Reason
for Recall		 Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.
FDA Determined
Cause 2		 Other
Action Notified consignees by letter on 04/04/2005.
Quantity in Commerce 297 units
Distribution Nationwide, Military medical center, Canada, and Czech Republic
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LSZ and Original Applicant = BUNNELL, INC.
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