Medtronic recalls Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and…

Recall date

July 8, 2016

Source

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

Recall number

Z-2554-2016

FDA classification

Class II

Brand / firm

Medtronic

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

Why it was recalled

Potential for compromise of the package resulting in a breach of the sterile barrier

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

What was recalled

Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable