FDAFDA · Food and drugs·Recall number Z-1185-2018
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
Published April 4, 2018 · Recall initiated: December 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- Worldwide Distribution - U.S. Nationwide in the states of: CA, CO, FL, IN, MA, NE, NJ, OH, TN, TX, and WI. and countries of Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Italy, Japan, Poland, Saudi Arabia, Spain, and United Kingdom.
- Lot
- Lot Numbers: 5667080 (Expiration Date: 11/30/2019), NS6127577 (Expiration Date: 4/30/2020)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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