PlainRecalls
FDA Devices Moderate Class II Ongoing

Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

Reported: April 12, 2023 Initiated: February 13, 2023 #Z-1348-2023

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.

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
190 units
Distribution
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.
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060. Recalled by CooperSurgical, Inc.. Units affected: 190 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 12, 2023. Severity: Moderate. Recall number: Z-1348-2023.