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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Product Detail

Product Description Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Recall Number Z-1361-2013
Classification Class II
Code Info Lot number 082712-03
Product Distributed Qty 39 boxes with 12 units each.
Reason For Recall Product coatings require 510K approval.

Event Detail

Event Id 64931
Product Type Devices
Status Ongoing
Recalling Firm Progressive Medical Inc
City Saint Louis
State MO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.