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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 64851
Product Type Devices
Status Ongoing
Recalling Firm Newport Medical Instruments Inc
City Costa Mesa
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-05
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Model number: HT70 and HT70 Plus Power Pac battery serial number range: 2096134110001 to 2292048120050, Rev. C through Rev. F Class I Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. 2528 ventilators and 1864 power pac batteries Z-1171-2013