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Recall Observatory FDA recall evidence

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

February 13, 2023

Class II

Product summary

Firm
CooperSurgical, Inc.
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

    reason.no_named_rule · v1.0.0

    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.