Device product
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Z-2152-2024
Product summary
- Event
- Event 94708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 630 units
- Official record key
device-enforcement:Z-2152-2024
Official wording
Reason: The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
Code information: Part 6210-9-900, UDI-DI: 07613327217902, Lot#: All lots back to 2006.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, Denmark, Hong Kong, Iran, Italy, Japan, Kuwait, Mexico, New Zealand, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, UK, Venlo.
Derived failure modes
-
Unknown
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.