Recall Z-1836-2017— COVIDIEN MEDTRONIC

Name: FDA recall Z-1836-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-26

Class II · Terminated

Class II FDA medical device recall by COVIDIEN MEDTRONIC, initiated 2017-01-26, terminated 2018-08-08. It names one FDA 510(k) clearance: K964175. Product: 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.. Reason: Customer reports of the device handset continuing to operate after release of the activation button..

Recalling firm: COVIDIEN MEDTRONIC
Classification: Class II
Status: Terminated
Initiated: 2017-01-26
Terminated: 2018-08-08
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K964175 — VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODESValleylab, Inc.·cleared 1996-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.