Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
This recall has been terminated (originally issued February 27, 2013).
- Company
- Myco Medical Supplies Inc
- Recall Initiated
- February 7, 2013
- Posted
- February 27, 2013
- Terminated
- July 9, 2013
- Recall Number
- Z-0891-2013
- Quantity
- 110,768 scalpels in individual pouches
- Firm Location
- Cary, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
Distribution
Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
Lot / 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.
Root Cause
Packaging
Action Taken
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.