FDA-Device2019-08-14Class II
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
Integra LifeSciences Corp.
Hazard
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Sold states
KY,NJ, RI, TX, WA Foreign: BE
Affected count
125 units
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2206-2019Don't want to check this manually?
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