Home / Recalls / Medical Devices
LivaNova USA recalls Perfusion Pack, Rx only, Sterile EO
Recalled January 30, 2019 · FDA recall Z-0770-2019 · 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. · FDA Class II
Units
483
Sold at
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
Description
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.
Product
Perfusion Pack, Rx only, Sterile EO
Manufacturer(s)
LivaNova USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →