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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64434
Product Type Devices
Status Ongoing
Recalling Firm Myco Medical Supplies Inc
City Cary
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-07
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Technocut Plus,Sterile Single Use Safety Scalpel, Distributed by: Myco Medial Cary, NC 27513. The Technocut Plus Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology, and minor medical procedures. Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116. Class II Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. 110,768 scalpels in individual pouches Z-0891-2013