Device recall
Z-2851-2016: Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing…
FDA device recall · Class III · CooperSurgical, Inc.
Key facts
| Recall number (Z-number) | Z-2851-2016 |
|---|---|
| Recall event | 75094 |
| 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… |
| Product code | MQL |
| Recalling firm | CooperSurgical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 1, 2017 |
| 510(k) numbers | K991390 |
| FEI number | 1216677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database