FDAFDA · Food and drugs·Recall number Z-2009-2012
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Published July 25, 2012 · Recall initiated: June 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
- Lot
- Catalog number: 801763 and serial number: 0011-0335,0337-0610, 1001-1034, 1037-1049,1100, 1103-1106, 1109-1445,and 1447-1450.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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