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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0014M-- Lot # 050609-05, 052909-05, 062309-04. Product Usage: Intended for cutting and coagulation of soft tissue.
Recall Number Z-2296-2012
Classification Class II
Code Info Lot # 050609-05, 052909-05, 062309-04.
Product Distributed Qty 3600 each
Reason For Recall On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.

Event Detail

Event Id 61982
Product Type Devices
Status Terminated
Recalling Firm Unimed Surgical Products, Inc.
City Largo
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-06-16
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US Nationwide Distribution - including the state of IL.
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