Recall Z-0891-2013
Myco Medical Supplies Inc · initiated February 7, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Codes / lots: 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.
Reason for recall
Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
FDA-determined 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.
Details
- Recall number
- Z-0891-2013
- Initiated
- February 7, 2013
- Posted by FDA
- February 27, 2013
- Terminated
- July 9, 2013
- Product code
- GDX – Scalpel, One-Piece
- 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
- Recalling firm
- Myco Medical Supplies Inc, Cary, NC