Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and ...
FDA Recall #Z-1348-2023 — Class II — February 13, 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.
Recalling Firm
CooperSurgical, Inc. — Trumbull, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
UDI-DI: 00815965020433; LOT 221118-010694
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated