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.
FDA Recall Z-1836-2017 · Posted None
Recalling FirmCOVIDIEN MEDTRONIC
Recall StatusTerminated
Product CodeGEI
Date Initiated2017-01-26
Date Terminated2018-08-08
Product Quantity24,703 Units
Reason for Recall
Customer reports of the device handset continuing to operate after release of the activation button.
Firm Action
A recall was initiated on January 26, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.