Device product
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Z-0133-2017
Product summary
- Event
- Event 74774
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0133-2017
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