FDA-Device2015-11-25Class II
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Ethicon Endo-Surgery Inc
Hazard
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
Sold states
Distributed US (nationwide) including the District of Columbia & Puerto Rico and in the countries of ARUBA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, ECUADOR, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, MEXICO, PANAMA, PERU, PHILIPPINES, SINGAPORE, SINGAPORE, THAILAND, TAIWAN & VIETNAM.
Affected count
441,490 pieces
Manufactured in
4545 Creek Rd, N/A, Blue Ash, OH, United States
Products
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0278-2016Don't want to check this manually?
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