Valleylab Laparoscopic Handset recalled over sterility concerns

Recall date

January 26, 2017

Source

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

Official notice title

COVIDIEN MEDTRONIC recalls Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usa…

Recall number

Z-1836-2017

FDA classification

Class II

Brand / firm

COVIDIEN MEDTRONIC

Sold / distributed

Worldwide - US Nationwide Distribution in the states of: AR AZ CA CO FL GA IA IL KS KY LA MA MI MN MO MS NC NE NM NY OH OR PA SC SD TN TX VA WA WV

Why it was recalled

Customer reports of the device handset continuing to operate after release of the activation button.

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 Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product Usage: For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.