Device product
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Z-1348-2023
Product summary
- Event
- Event 91794
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 190 units
- Official record key
device-enforcement:Z-1348-2023
Official wording
Reason: It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
Code information: UDI-DI: 00815965020433; LOT 221118-010694
Distribution pattern: Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.
Derived failure modes
-
Unknown
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.