FDA Device recall Z-1348-2023
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
- FDA Device
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060 by Coopersurgical, citing 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 sourc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1348-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-13 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
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.
Identifiers
| code_info | UDI-DI: 00815965020433; LOT 221118-010694 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1348-2023%22
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