Device recall
Z-0248-2022: Vit Kit-Freeze is intended for use in assisted reproductive procedures for…
FDA device recall · Class II · Fujifilm Irvine Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-0248-2022 |
|---|---|
| Recall event | 88720 |
| Product | Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw… |
| Product code | MQL |
| Recalling firm | Fujifilm Irvine Scientific, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160006 |
| FEI number | 2022379 |
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