HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis recalled over fire hazard

Recall date

September 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ethicon Endo-Surgery Inc recalls HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated…

Recall number

Z-0278-2016

FDA classification

Class II

Brand / firm

Ethicon Endo-Surgery Inc

Sold / distributed

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 & VIET…

Why it was recalled

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.