Device product
JAGTOME RX 44-30-260-035 Material Number: M00573060
Z-0775-2022
Product summary
- Event
- Event 89468
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2209 units
- Official record key
device-enforcement:Z-0775-2022
Official wording
Reason: Sterility of device is compromised due to a sterile barrier breach
Code information: Lot Numbers: Batch 27522394 27566792 27589267 27618168 27726335 27758466 27795807 27822419 27458135 27472063 27553565 27649356 27706277 27758465 27773622 27821544 27865086 27986549 28017367 28289453 GTIN: 8714729776673
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