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

Recalled November 25, 2015 · FDA recall Z-0278-2016 · Ethicon Endo-Surgery

Hazard

Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. · FDA Class II

Units

441,490 pieces

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Ethicon Endo-Surgery Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →