Device product
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Z-0135-2017
Product summary
- Event
- Event 74774
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0135-2017
Official wording
Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Code information: Beginning Lot Code 110609X to Ending Lot Code 20160308X
Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
Derived failure modes
-
Sterility assurance
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility