Device product
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Z-0891-2013
Product summary
- Event
- Event 64434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110,768 scalpels in individual pouches
- Official record key
device-enforcement:Z-0891-2013
Official wording
Reason: Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
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.
Distribution pattern: Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
Derived failure modes
-
Labeling or packaging
defective packaging
-
Sterility assurance
compromised sterility