FDA-Device2021-09-01Class II
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Ethicon Endo-Surgery Inc
Hazard
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.
Affected count
68960 units
Manufactured in
4545 Creek Rd, N/A, Blue Ash, OH, United States
Products
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2356-2021Don't want to check this manually?
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