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Recall Observatory FDA recall evidence

Device product

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.

Z-0484-2015

October 27, 2014

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 69636
Status
Terminated
Classification
Class II
Quantity
595 units
Official record key
device-enforcement:Z-0484-2015

Official wording

Reason: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode

Code information: Lot 159621 Exp Date: 2017-05

Distribution pattern: Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled