Recall Z-1836-2017 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
COVIDIEN MEDTRONIC
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.
| Date | Jan 26, 2017 |
| Status | Terminated |
| Reason | Customer reports of the device handset continuing to operate after release of the activation button. |
| Root cause | Device Design |
| 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. |
| Quantity | 24,703 Units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964175 | VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES Valleylab, Inc., Dec 5, 1996 |