FDAFDA · Food and drugs·Recall number Z-2019-2014
Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS)
Published July 16, 2014 · Recall initiated: June 17, 2014
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
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Distributor
- Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, 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 AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.
- Lot
- Catalog Number 801764
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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