Recall Z-0484-2015 ยท HGI Electrocautery, Gynecologic (And Accessories)
CooperSurgical, Inc.
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
| Date | Dec 2, 2014 (initiated Oct 27, 2014) |
| Status | Terminated |
| Reason | Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode |
| Root cause | Packaging process control |
| Action | CooperSurgical issued recall letter dated October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form. Customers with questions were instructed to call 203-601-5200. |
| Quantity | 595 units |
| Distribution | Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905747 | LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR Coopervision Surgical, Sep 17, 1991 |