Device recall
Z-1185-2018: Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1185-2018 |
|---|---|
| Recall event | 79471 |
| Product | Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use |
| Product code | KYZ |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2019 |
| FEI number | 1820334 |
At a glance
- None 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