Z-2206-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- July 19, 2019
- Termination Date
- May 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 units
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
Distribution Pattern
KY,NJ, RI, TX, WA Foreign: BE
Code Information
Lot # J2670Y