Z-0484-2015 Class II Terminated
FDA device recall Z-0484-2015 was initiated by CooperSurgical, Inc. on Oct 27, 2014 and is designated Class II. Reason for recall: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode The recall status is terminated (terminated May 29, 2015). Affected quantity: 595 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 3, 2014
- Initiation Date
- Oct 27, 2014
- Termination Date
- May 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 595 units
Product Description
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.
Reason for Recall
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Distribution Pattern
Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
Code Information
Lot 159621 Exp Date: 2017-05
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0484-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026