Device product
JAGTOME RX 44-20-450-035 Material Number: M00573050
Z-0774-2022
Product summary
- Event
- Event 89468
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3578 units
- Official record key
device-enforcement:Z-0774-2022
Official wording
Reason: Sterility of device is compromised due to a sterile barrier breach
Code information: Lot Numbers: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.
Derived failure modes
-
Sterility assurance
compromised due to a sterile barrier