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
Product summary
- 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
mislabeled