Z-1348-2023 Class II Ongoing
FDA device recall Z-1348-2023 was initiated by CooperSurgical, Inc. on February 13, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 190 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2023
- Initiation Date
- February 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
Product Description
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Reason for Recall
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.
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.
Code Information
UDI-DI: 00815965020433; LOT 221118-010694