Recall Z-1185-2018— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2017-12-19, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-19
- Terminated
- 2019-04-09
- Firm location
- Bloomington, IN, United States
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.