Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable compone

FDA device recall Z-0514-2013 · posted 2012-12-14 · Terminated

Recall details

Recalling firm

Bunnell, Inc.

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.

Action taken

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

Root cause

Component design/selection

Status

Terminated

Product code

LSZ

Quantity affected

5743 patient circuits distributed in commerce

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).

Date initiated

2012-11-19

Date posted

2012-12-14

Date terminated

2014-02-21

Location

Salt Lake City, UT