Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2206-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-07-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2206-2019
Date of alert
2019-07-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corp.
Product category
device
Product type
Devices
Reported risk: Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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