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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description 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.
Recall Number Z-0891-2013
Classification Class II
Code Info 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.
Product Distributed Qty 110,768 scalpels in individual pouches
Reason For Recall Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.

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