Class 2 Device Recall High Frequency Ventilator

• Date Initiated by Firm: April 04, 2005
• Date Posted: May 23, 2006
• Recall Status: Terminated 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.
• FEI Number: 3032745446
• 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: 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