Events

Recall of Device Recall NormJect Tuberkulin Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79471
  • Event Risk Class
    Class 2
  • Event Number
    Z-1185-2018
  • Event Initiated Date
    2017-12-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162422
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Syringe, irrigating (non dental) - Product Code KYZ
  • 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.
  • Action
    Cook Medical sent an Urgent Medical Device Recall dated December 19, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Examine inventory immediately and quarantine affected product(s). 2. Return products to Cook with the Acknowledgement and Receipt Form to receive a product credit. 3. Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter. 4.Report adverse events to Cook. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

Device

Device Recall NormJect Tuberkulin Syringe
  • Model / Serial
    Lot Numbers: 5667080 (Expiration Date: 11/30/2019), NS6127577 (Expiration Date: 4/30/2020)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • 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
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Manufacturer Address
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA