CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling
CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error on the outer box without reported injuries or illnesses.
Plain-English summary
CooperSurgical, Inc. is recalling 595 units of LEEP Radius Loop Electrodes (Model R2010). The product is intended for the diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
The recall was initiated because the outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode. The affected units are from Lot 159621 with an expiration date of 2017-05.
The affected units were distributed nationwide in the United States and internationally to Canada, Portugal, and Hong Kong. Consumers and healthcare providers should stop using the product and contact the manufacturer for instructions.
The recalled product
- 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.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 595
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 159621 Exp Date: 2017-05
Distribution
Distributed nationwide across the United States.
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