Recall Z-0257-2022 ยท HGI Electrocautery, Gynecologic (And Accessories)
CooperSurgical, Inc.
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
| Date | Sep 29, 2021 |
| Status | Open, Classified |
| Reason | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. |
| Root cause | Component design/selection |
| Action | CooperSurgical issued Urgent Medical Device Recall to consignees via certified mail with confirmed delivery receipt dated 9/29/21. Letter states reason for recall, health risk and action to take: This Recall affects 2955 units manufactured since product launch in December 2009 and a corrective action has been initiated to prevent future recurrence. Please discontinue use of this product, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for repair of your device at CooperSurgical s expense, including shipping, and return of the product to you. Plea |
| Quantity | 1587 Units |
| Distribution | US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963348 | WALLACH INTEGRATION UNIT Wallach Surgical Devices, Inc., Mar 19, 1997 |