Recall Z-0891-2013 ยท GDX Scalpel, One-Piece
Myco Medical Supplies Inc
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
| Date | Feb 27, 2013 (initiated Feb 7, 2013) |
| Status | Terminated |
| Reason | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. |
| Root 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 pro |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.