FDA-Device2017-04-26Class II

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.

COVIDIEN MEDTRONIC
Hazard

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

Sold states
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
Affected count
24,703 Units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1836-2017

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