Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
FDA Recall Z-0891-2013 · Posted 2013-02-27
Recalling FirmMyco Medical Supplies Inc
Recall StatusTerminated
Product CodeGDX
Date Initiated2013-02-07
Date Terminated2013-07-09
Product Quantity110,768 scalpels in individual pouches
Reason for Recall
Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
Firm 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 [email protected] 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.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.