Z-1185-2018 Class II Terminated
FDA device recall Z-1185-2018 was initiated by Cook Inc. on December 19, 2017 and is designated Class II. 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 nonviab… The recall status is terminated (terminated April 9, 2019). Affected quantity: 1900.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- December 19, 2017
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1900
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.
Distribution Pattern
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.
Code Information
Lot Numbers: 5667080 (Expiration Date: 11/30/2019), NS6127577 (Expiration Date: 4/30/2020)