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
Reported: August 14, 2019 Initiated: July 19, 2019 #Z-2206-2019
Product Description
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
Reason for Recall
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 125 units
- Distribution
- KY,NJ, RI, TX, WA Foreign: BE
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Integra LifeSciences Corp.. Units affected: 125 units.
Why was this product recalled? ▼
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2206-2019.
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