FDA Device recall Z-2851-2016
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezin…
- 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) Thawing Medium Product Number: ART-8018 Intended for use in freezin… 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-2851-2016 |
| 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) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
Reason
Products contain international package insert and not the correct USA package insert
Identifiers
| code_info | Lot no 16140184 expires April 2017 Lot no 15430149 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-2851-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.