FDA Device recall Z-1185-2018
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (I…
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (I… by Cook, citing certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable g….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1185-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-19 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | US |
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
Reason
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
Identifiers
| code_info | Lot Numbers: 5667080 (Expiration Date: 11/30/2019), NS6127577 (Expiration Date: 4/30/2020) |
|---|
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-1185-2018%22
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