Recall Z-1360-2013— Progressive Medical Inc

Name: FDA recall Z-1360-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-12

Class II · Terminated

Class II FDA medical device recall by Progressive Medical Inc, initiated 2013-04-12, terminated 2014-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries. Reason: Product coatings require 510K approval..

Recalling firm: Progressive Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-12
Terminated: 2014-05-07
Firm location: Fenton, MO, United States

Product description

Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

Reason for recall

Product coatings require 510K approval.

Data sourced from openFDA. This site is unofficial and independent of the FDA.