FDA-Device2016-11-23Class III
RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
Stryker Instruments Div. of Stryker Corporation
Hazard
Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.
Sold states
Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden VA/DOD:
Affected count
2,675
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0584-2017Don't want to check this manually?
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