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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Technocut Plus,Sterile Single Use Safety Scalpel.
see related information
Date Posted February 27, 2013
Recall Status1 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, North Carolina 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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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