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.
Reported: November 25, 2015 Initiated: September 23, 2015 #Z-0278-2016
Product Description
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.
Reason for Recall
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 441,490 pieces
- Distribution
- 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.
- Location
- Blue Ash, OH
Frequently Asked Questions
What product 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.. Recalled by Ethicon Endo-Surgery Inc. Units affected: 441,490 pieces.
Why was this product recalled? ▼
Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0278-2016.
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