FDAFDA · Food and drugs·Recall number Z-0484-2015
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.
Published December 3, 2014 · Recall initiated: October 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperSurgical, Inc.
- Distributor
- Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
- Lot
- Lot 159621 Exp Date: 2017-05
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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