Reported Aug 14, 2019 · Terminated
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during…
Integra LifeSciences Corp.
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: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
- Lot codes and dates
- Lot # J2670Y
- Amount recalled
- 125 units
Where it was sold
Why it was recalled
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
This product could cause temporary or reversible health problems — stop using it.
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