Recall Z-0514-2013 ยท LSZ Ventilator, High Frequency
Bunnell, Inc.
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
| Date | Dec 14, 2012 (initiated Nov 19, 2012) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 5743 patient circuits distributed in commerce |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.