Z-2293-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2012
- Initiation Date
- June 16, 2010
- Termination Date
- August 30, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2400 each
Product Description
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***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 # ES0014AM -- Lot # 050409-05, 050609-05. Product Usage: Intended for cutting and coagulation of soft tissue.
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.
Distribution Pattern
US Nationwide Distribution - including the state of IL.
Code Information
Lot # 050409-05, 050609-05.