Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Flight Medical Innovations Ltd. Provides Update on
Recall of Ventilator Remote Alarm Cable

Contact:
Consumer:
+972 8 9235111

FOR IMMEDIATE RELEASE - February 12, 2012 –Flight Medical Innovations Ltd. (Flight Medical) issued the following update regarding its voluntary recall of remote alarm cable, part number V24-00400-29, used to connect a Newport HT50 mechanical ventilator to a nurse station.  The recalled cable may negatively affect Newport HT50 ventilators manufactured prior to 2007.  Affected units may shutdown unexpectedly. The FDA has classified this action as a Class I recall.

On August 23, 2011, Flight Medical sent an urgent Recall Notice to affected customers through its distributor, Newport Medical Instruments, Inc.  (Newport Medical), to stop using the alarm cable immediately and to contact Newport Medical in order to receive an upgraded version of the cable.

Flight Medical initiated the recall in August 2011, which affected 363 cables.  The affected devices were distributed between April 25, 2007 and July 6, 2011.  A total of 328 cables were distributed within the US.  An additional 22 cables were distributed outside the US.  13 cables remained in the distributor’s warehouse.

Newport Medical, on behalf of Flight Medical, issued notification letters to 43 customers that received the affected cables.  In the notification letter, the customers were notified of the affected cables and that an upgraded version of the cable would be provided to them free of charge.  Customers, including Newport Medical are requested to dispose of the affected cables properly
Instructions to customers:
Customer inquiries related to this action should be addressed to Newport’s Technical Service Group at (800) 4513111, extension 500.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.  Online: www.fda.gov/medwatch/reports.htm; By regular mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm.  Mail to address on the pre-addressed form;  and by fax at 1-800-FDA-0178.

About Flight Medical Innovations Ltd.
Flight Medical is a developer, manufacturer and marketer of portable ventilators. The company has a number of portable ventilators models marketed worldwide under the brand names Flight 60, Flight 50 and Newport HT50 (through Newport Medical).  Flight Medical’s ventilators cover a wide range of invasive and non-invasive ventilation needs and are used in a wide range of settings from ICU units to Home Care.  For more information, please visit www.flight-medical.com.

###

RSS Feed for FDA Recalls Information [what's this?]

-