Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***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 # ES0009 -- Lot # 052709-01 Product Usage: Intended for cutting and coagulation of soft tissue. |
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| Recall Number | Z-2294-2012 |
| Classification | Class II |
| Code Info | Lot # 052709-01 |
| Product Distributed Qty | 1200 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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