Device product
JAGTOME RX 44-30-450-035 Material Number: M00573070
Z-0776-2022
Product summary
- Event
- Event 89468
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 163 units
- Official record key
device-enforcement:Z-0776-2022
Official wording
Reason: Sterility of device is compromised due to a sterile barrier breach
Code information: Lot Numbers: Batch 27737251 27970819 28289451 27821545 28019275 GTIN: 8714729776543
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