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

Recall Z-1364-2013 — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries

U.S. FDA — Device Enforcement · United States · 2013-04-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1364-2013
Date of alert
2013-04-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Progressive Medical Inc
Product category
device
Product type
Devices
Reported risk: Product coatings require 510K approval.
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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