FDA Device recall Z-2850-2016
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertiliza…
- FDA Device
- Class III
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class III recall of Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertiliza… by Coopersurgical, citing products contain international package insert and not the correct USA package insert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2850-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-25 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA
Reason
Products contain international package insert and not the correct USA package insert
Identifiers
| code_info | Lot No. 15420123 Expires Oct. 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2850-2016%22
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