Class 2 Device Recall Technocut Plus,Sterile Single Use Safety Scalpel.

• Date Initiated by Firm: February 07, 2013
• Date Posted: February 27, 2013
• Recall Status: Terminated on July 09, 2013
• Recall Number: Z-0891-2013
• Recall Event ID: 64434
• Product Classification: Scalpel, one-piece - Product Code GDX
• Product: Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Myco Medical Supplies Inc; 158 Towerview Ct; Cary NC 27513
• For Additional Information Contact: Tim Krotchko; 919-460-2535 Ext. 105
• Manufacturer Reason for Recall: Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
• FDA Determined Cause: Packaging
• Action: MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email QA@mycomedical.com or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535. For questions regarding this recall call 919-460-2535, ext 105.
• Quantity in Commerce: 110,768 scalpels in individual pouches
• Distribution: Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.