FDA recall Z-2206-2019

Product

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

KY,NJ, RI, TX, WA Foreign: BE

Key facts

Status

Terminated

Initiation date

2019-07-19

Report date

2019-08-14

Termination date

2020-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2206-2019