Medical Devices
Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator
Recall Class: Class I
Date Recall Initiated: August 10, 2011
Product: V24-00400-29 cable for Flight Medical Newport HT50 ventilator. The affected cables were distributed between April 25, 2007 and July 6, 2011. A total of 328 cables were distributed within the US.
Use: The V24-00400-20 cable is an accessory intended to transfer the alarm signal from a Newport HT50 ventilator to a nurse station.
Recalling Firm:
Flight Medical Ltd.
13 Hamelacha Street
Lod, Israel
Reason for Recall: The recalled cable may cause an electrical shortage that can cause Newport HT50 ventilators manufactured prior to 2007 to shutdown unexpectedly.
Public Contact: Customer with questions about this recall can call Newport Medical’s Technical Service Group at 1-800-451-3111, extension 500.
FDA District: Los Angeles
FDA Comments: On August 23, 2011, Flight Medical sent an urgent Recall Notice to affected customers through its distributor, Newport Medical Instruments, Inc. (Newport Medical). Affected customers were advised to take the following actions:
- Stop using the alarm cable immediately.
- Contact Newport Medical in order to receive an upgraded version of the cable free of charge.
- Customer inquiries related to this action should be addressed to Newport Medical’s Technical Service Group at 1-800-451-3111, extension 500.
- Affected cables should be disposed of according to local municipal guidelines.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX.
Additional Information:
Company Press Release
