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U.S. Department of Health and Human Services

Class 1 Device Recall Life Pulse High Frequency Ventilator

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 Class 1 Recall
Life Pulse High Frequency Ventilator
see related information
Date Posted December 14, 2012
Recall Status1 Terminated on February 21, 2014
Recall Number Z-0514-2013
Recall Event ID 63710
Premarket Approval
PMA Number
P850064
Product Classification Ventilator, High Frequency - Product Code LSZ
Product Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.
Code Information Patient Circuit (catalog # 902) lot # on each individual patient circuit label: 12C092, 12C102, 12C115, 12C125, 12C136, 12D159, 12D172, 12D189, 12E204, 12E211, 12E224, 12F241, 12F254, 12F271, 12G279, 12G290, 12G307, 12G321, 12H330, 12H349, 12I362, 12I371, 12I397, 12J413, 12J430, 12J448, 12K457, 12K471 Patient Circuit Kit (catalog # 397) lot # on the label on outside of box: 12C099, 12C114, 12C124, 12C135, 12D152, 12D170, 12D188, 12E203, 12E210, 12E223, 12F238, 12F255, 12F274, 12G209, 12G280, 12H334, 12H341, 12I356, 12I369, 12I392, 12J411, 12J425, 12J447, 12K467, 12K479
Recalling Firm/
Manufacturer
Bunnell, Inc.
436 Lawndale Dr
Salt Lake City, Utah 84115-2917
Manufacturer Reason
for Recall
Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action On 12/5/12, the firm, Brunnell, Inc., issued a public press notification to their consignees. A. On or before 12-12-2012 a certified letter will be sent to all customer listed in the customer database. Specifically each customer will receive two certified letters; one directed to Director of Respiratory Therapy and a second to the Director of Biomedical Engineering. The certified letter will contain a copy of the Recall Noticeand a copy of the Certificate of Medical Necessity. The Certified Letter receipts will be maintained. On the mailing date a copy of the Recall Notice will be placed on the Bunnell website. B. An Excel database will be maintained for each customer/lot #. The database will contain the current status for each. Included will be: 1. Customer Information 2. Date Certified Letter Sent 3. Date receipt received and filed 4. Date product returned or that no stock remains 5. Lot number & Quantity C. On or before 02-01-2013, a second letter will be sent to those customers who have not responded to the original certified letter. D. Data will be maintained in the database E. On or before 04-01-2013, a phone call will be placed to those customers who have not responded to either of the letters. F. Data will be maintained in the database G. On or before 04-15-2013, a second phone call will be placed to those customers who have not responded to the letters or previous phone call. H. Data will be maintained in the database I. On or before 06-07-2013, a Final Recall Notification certified letter will be sent to those customers who have not responded to either of the previous letters or phone calls. J. The Certified Letter receipt will be maintained K. Data will be maintained in the database L. When PMA for alternate heater wire is approved, steps A-K will be repeated. Dates will be determined. M. Following completion of Step L, a final review of the database will occur. Final tabulation of the status for each custo.
Quantity in Commerce 5743 patient circuits distributed in commerce
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LSZ and Applicant = BUNNELL, INC.
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