Device product
DREAMTOME 44-30MM/260CM Material Number: M00584050
Z-0753-2022
Product summary
- Event
- Event 89468
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12067 units
- Official record key
device-enforcement:Z-0753-2022
Official wording
Reason: Sterility of device is compromised due to a sterile barrier breach
Code information: Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271
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