Device product
CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for
Z-0131-2017
Product summary
- Event
- Event 74774
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0131-2017
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