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.
FDA Recall Z-0484-2015 · Posted 2014-12-02
Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHGI
Date Initiated2014-10-27
Date Terminated2015-05-29
Product Quantity595 units
Reason for Recall
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
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.