Recall Z-0514-2013— Bunnell, Inc.

Class I FDA medical device recall by Bunnell, Inc., initiated 2012-11-19, terminated 2014-02-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Bunnell, Inc.

Classification

Class I

Status

Terminated

Initiated

2012-11-19

Terminated

2014-02-21

Firm location

Salt Lake City, UT, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.