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

Recall Z-1719-2014 — MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

U.S. FDA — Device Enforcement · United States · 2014-05-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1719-2014
Date of alert: 2014-05-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ConMed Corporation
Product category: device
Product type: Devices

Reported risk: ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1719-2014 — MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

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