FDA-Device2019-01-30Class II
Perfusion Pack, Rx only, Sterile EO
LivaNova USA
Hazard
4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.
Sold states
Worldwide Distribution - Domestic (US) Consignees: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV, MS; Foreign (OUS) Consignees: Canada
Affected count
483
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
Perfusion Pack, Rx only, Sterile EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0770-2019Don't want to check this manually?
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