Reported Dec 3, 2014 · Terminated
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…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 75 Vista Pl · Trumbull, CT · 06611-3934
Is this the product you have?
- 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 UseDiagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract
- Lot codes and dates
- Lot 159621 Exp Date2017-05
- Amount recalled
- 595 units
Where it was sold
- Nationwide
Why it was recalled
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
This product could cause temporary or reversible health problems — stop using it.
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