Device product
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Z-0759-2022
Product summary
- Event
- Event 89468
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7695 units
- Official record key
device-enforcement:Z-0759-2022
Official wording
Reason: Sterility of device is compromised due to a sterile barrier breach
Code information: Lot Numbers: 27439836 27440919 27493069 27496980 27499896 27750785 27753215 27825981 27879216 27880741 27931764 27934862 28032489 28043447 GTIN: 8714729755197
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