Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-1185-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 19, 2017

Date Posted: April 4, 2018

Recall Number: Z-1185-2018

Event ID: 79471

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.

Status: Terminated

Product Quantity: 1900

Code Information:

Lot Numbers: 5667080 (Expiration Date: 11/30/2019), NS6127577 (Expiration Date: 4/30/2020)

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.

Voluntary or Mandated:

Voluntary: Firm initiated