Device recall
Z-1324-2012: Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at…
FDA device recall · Class II · Cook, Inc.
Key facts
| Recall number (Z-number) | Z-1324-2012 |
|---|---|
| Recall event | 61177 |
| Product | Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, Product Usage: Culture oil is intended to be used as an oil overlay for cultures of gametes, zygotes, or embryos in assisted reproductive technology (ART) and… |
| Product code | MQL |
| Recalling firm | Cook, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 3, 2012 |
| 510(k) numbers | K022002 |
| FEI number | 1820334 |
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